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Chemistry

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Also known as: 7447-40-7, Sylvite, Klotrix, Enseal, Slow-k, Klor-con
Molecular Formula
ClK
Molecular Weight
74.55  g/mol
InChI Key
WCUXLLCKKVVCTQ-UHFFFAOYSA-M
FDA UNII
660YQ98I10

Potassium Chloride
A white crystal or crystalline powder used in BUFFERS; FERTILIZERS; and EXPLOSIVES. It can be used to replenish ELECTROLYTES and restore WATER-ELECTROLYTE BALANCE in treating HYPOKALEMIA.
1 2D Structure

Potassium Chloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
potassium;chloride
2.1.2 InChI
InChI=1S/ClH.K/h1H;/q;+1/p-1
2.1.3 InChI Key
WCUXLLCKKVVCTQ-UHFFFAOYSA-M
2.1.4 Canonical SMILES
[Cl-].[K+]
2.2 Other Identifiers
2.2.1 UNII
660YQ98I10
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Chloride, Potassium

2. Slow-k

2.3.2 Depositor-Supplied Synonyms

1. 7447-40-7

2. Sylvite

3. Klotrix

4. Enseal

5. Slow-k

6. Klor-con

7. Muriate Of Potash

8. Neobakasal

9. Potassium Monochloride

10. Chlorvescent

11. Kalitabs

12. Kaochlor

13. Potavescent

14. Kloren

15. Pfiklor

16. Rekawan

17. Chloropotassuril

18. Kcl-retard Zyma

19. Klor-lyte

20. K-contin

21. Kay Ciel

22. Monopotassium Chloride

23. K-lease

24. Kaon Cl

25. Kaon-cl

26. Micro-k

27. Potassium Chloride (kcl)

28. Chloride Of Potash

29. K-lor

30. K-tab

31. Ten-k

32. Kay-em

33. Potassiumchloride

34. Kaliumchlorid

35. Micro-k Ls

36. Kali Muriaticum

37. Emplets Potassium Chloride

38. Kaon-cl 10

39. Potassium;chloride

40. Sylvite (kcl)

41. Kaon Cl-10

42. Micro-k 10

43. Kcl

44. Potassium Chloride Solution

45. Sylvine

46. K+10

47. Chloride (as Potassium)

48. Steropotassium

49. Acronitol

50. Kaliduron

51. Kaliglutol

52. Kalilente

53. Kaliolite

54. Miopotasio

55. Durekal

56. Durules

57. Kadalex

58. Kalcorid

59. Kaleorid

60. Kalinorm

61. Kalipor

62. Kalipoz

63. Keylyte

64. Klorvess

65. Mfcd00011360

66. Nsc-77368

67. Potasion

68. Potasol

69. Celeka

70. Enpott

71. 14336-88-0

72. Natural Sylvite

73. Kato

74. Kalium Duriles

75. Kalium Durules

76. Kalium-durettes

77. Rekawan Retard

78. Kalium Retard

79. Lento-kalium

80. Peter-kal

81. Kalitrans Retard

82. Potassium Muriate

83. Durules-k

84. Kalium-r

85. Kay-ciel

86. Repone K

87. Diffu-k

88. Kalinor-retard P

89. Kalium Sr

90. Lento-k

91. Super K

92. Ultra K Chlor

93. Ultra-k-chlor

94. Kcl Retard

95. Addi-k

96. Cena-k

97. Ins No.508

98. K-care

99. K-grad

100. K-norm

101. Span-k

102. Clor-k-zaf

103. Potassium Chloride,ar,99.5%

104. Micro-k Extentcaps

105. Plus Kalium Retard

106. Potassium Chloride, Acs Reagent

107. Infalyte

108. Kayciel

109. Apo-k

110. Chebi:32588

111. K Tab

112. K-dur

113. K-lyte Cl

114. K-sol

115. Kay-cee-l

116. Leo-k

117. Micro-kalium Retard

118. Rum-k

119. Ins-508

120. Nu-k

121. Slow-k Tablets

122. Kalinorm Depottab

123. Tripotassium Trichloride

124. 660yq98i10

125. K+8

126. K-sr

127. Chlorid Draselny [czech]

128. Super K (salt)

129. Kaon-cl Tabs

130. Kalium S.r.

131. Klor-con M20

132. Chlorid Draselny

133. Potassium Cl

134. E 508

135. E-508

136. Buffer Solution, Ph 2.00

137. Buffer Solution, Ph 9.00

138. Potassium Chloride [jan]

139. Potassium Chloride, Ultra Dry

140. Klor-con M10

141. Klor-con M15

142. Potassium Chloride (k3cl3)

143. Caswell No. 686

144. Epiklor

145. Kali Chloratum

146. Kali Chloridum

147. Potassium, Reference Standard Solution

148. Potassii Chloridum

149. Klotrix (tn)

150. Klor-con (tn)

151. Ccris 1962

152. Klor-con 10

153. K-10

154. Hsdb 1252

155. Kaon-cl (tn)

156. K-dur (tn)

157. Potassium Chloride 10meq In Plastic Container

158. Potassium Thallium Chloride (ktlcl)

159. [kcl]

160. Einecs 231-211-8

161. Nsc 77368

162. Epa Pesticide Chemical Code 013904

163. Kcl (tn)

164. Potassium Chloride In Plastic Container

165. Kalii Chloridum

166. Potassium Chloride [usp:jan]

167. Unii-660yq98i10

168. Potassium Chloride 30meq In Plastic Container

169. Potassium Chloride 40meq In Plastic Container

170. Potassium Chloride Salt

171. Potassium Chloride,(s)

172. Potassium (as Chloride)

173. Potassium Chloride 20meq In Plastic Container

174. Wln: Ka G

175. Ec 231-211-8

176. Buffer Solution, Ph 1.01

177. Potassium(i) Chloride

178. B1653 [langual]

179. Isa (ionic Strength Adjustment Solution: 1 M Kcl)

180. Kali Muriaticum [hpus]

181. Potassium Chloride, Food Grade

182. Potassium Chloride [ii]

183. Potassium Chloride [mi]

184. Chembl1200731

185. Dtxsid5021178

186. Potassium Chloride (fru Grade)

187. Potassium Chloride [fcc]

188. Potassium Chloride Solution, 1m

189. Buffer Concentrate, Ph 10.01

190. Potassium Chloride (jp17/usp)

191. Potassium Chloride [hsdb]

192. Potassium Chloride [inci]

193. Potassium Chloride Solution, 1 M

194. Potassium Chloride Solution, 20%

195. Potassium Chloride, Optical Grade

196. Potassium Chloride [vandf]

197. Potassium Chloride, Lr, >=99%

198. Potassium Chloride [mart.]

199. Amy37139

200. Cs-b1714

201. Hy-y0537

202. Nsc77368

203. Potassium Chloride [usp-rs]

204. Potassium Chloride [who-dd]

205. Potassium Chloride [who-ip]

206. Potassium Chloride, Acs, 99.5%

207. Str03715

208. Potassium Chloride - Drilling Grade

209. Potassium Chloride Solution, 3.3 M

210. Potassium Chloride, Ar, >=99.5%

211. Akos015902779

212. Akos024438069

213. Akos024457458

214. Potassium Chloride 3m Aqueous Solution

215. Potassium Chloride Solution, 0.01 M

216. Db00761

217. Kalii Chloridum [who-ip Latin]

218. Potassium Chloride [orange Book]

219. Potassium Chloride, 1m Aqueous Solution

220. Chloride (as Potassium) [vandf]

221. Potassium (as Chloride) [vandf]

222. Potassium Chloride [ep Monograph]

223. Potassium Chloride, Bioxtra, >=99.0%

224. Potassium Chloride, Bp, Ph. Eur. Grade

225. E508

226. Potassium Chloride [usp Monograph]

227. Tham-e Component Potassium Chloride

228. Potassium Chloride Biochemical Grade = 99%

229. B7289

230. Ft-0645107

231. P1757

232. Potassium Chloride, Acs Reagent, >=99.0%

233. Potassium Chloride, P.a., 99.0-100.5%

234. Halflytely Component Potassium Chloride

235. Potassium Chloride (technical Grade, Type A)

236. Potassium Chloride (technical Grade, Type B)

237. Potassium Chloride Component Of Tham-e

238. Potassium Chloride, 99.997% (metals Basis)

239. Tis-u-sol Component Potassium Chloride

240. D02060

241. Potassium Chloride, Bioultra, >=99.5% (at)

242. Potassium Chloride, Reagentplus(r), >=99.0%

243. Potassium Chloride Component Of Halflytely

244. Potassium Chloride Component Of Tis-u-sol

245. Potassium Chloride Solution, In H2o (saturated)

246. Potassium Chloride, 99.999% Trace Metals Basis

247. Potassium Chloride, Saj First Grade, >=99.0%

248. Potassium Chloride, Tested According To Ph.eur.

249. Potassium Chloride, Trace Metals Grade 99.99%

250. Potassium Chloride, >=99.99% Trace Metals Basis

251. Potassium Chloride, 0.85m, Conductivity Standard

252. Potassium Chloride, Acs Reagent, 99.0-100.5%

253. Potassium Chloride, Jis Special Grade, >=99.5%

254. Potassium Chloride, Spectroscopy Grade, Ultrapure

255. Potassium Chloride, Usp Special, 99.0-100.5%

256. Potassium Chloride, Vetec(tm) Reagent Grade, 99%

257. Q184630

258. Potassium Chloride, 0.005m, Conductivity Standard

259. Potassium Chloride, 0.007m, Conductivity Standard

260. Potassium Chloride, 0.010m, Conductivity Standard

261. Potassium Chloride, 0.0145m, Conductivity Standard

262. Potassium Chloride, 0.0375m, Conductivity Standard

263. Potassium Chloride, 0.0765m, Conductivity Standard

264. Potassium Chloride, 0.117m, Conductivity Standard

265. Potassium Chloride, 0.159m, Conductivity Standard

266. Potassium Chloride, 1m Aqueous Solution, Rnase Free

267. Potassium Chloride, Puriss. P.a., >=99.5% (at)

268. Potassium Chloride Solution, Bioultra, ~3 M In H2o

269. Potassium Chloride, 0.00017m, Conductivity Standard

270. Potassium Chloride, 0.00068m, Conductivity Standard

271. Potassium Chloride, For Molecular Biology, >=99.0%

272. Potassium Chloride, ~0.000027m, Conductivity Standard

273. Potassium Chloride, Meets Ep, Usp Testing Specifications

274. Isa (ionic Strength Adjustment Solution: 1 M Kcl), 1 M Kcl

275. Potassium Chloride Crystal Optic Disc, 13mm X 2mm, Unpolished

276. Potassium Chloride Crystal Optic Disc, 25mm X 5mm, Unpolished

277. Potassium Chloride Crystal Optic Disc, 32mm X 3mm, Unpolished

278. Potassium Chloride Solution, Standard, Solution (volumetric), 1.0 M

279. Potassium Chloride, Bioultra, For Molecular Biology, >=99.5% (at)

280. Potassium Standard For Aas, Ready-to-use, Traceable To Bam, In H2o

281. Potassium Chloride Crystal Optic Disc, 13mm X 1mm, Polished Both Sides

282. Potassium Chloride Crystal Optic Disc, 13mm X 2mm, Polished Both Sides

283. Potassium Chloride Crystal Optic Disc, 22mm X 4mm, Polished Both Sides

284. Potassium Chloride Crystal Optic Disc, 25mm X 2mm, Polished Both Sides

285. Potassium Chloride Crystal Optic Disc, 25mm X 4mm, Polished Both Sides

286. Potassium Chloride Crystal Optic Disc, 32mm X 3mm, Polished Both Sides

287. Potassium Chloride Crystal Optic Disc, 38mm X 6mm, Polished Both Sides

288. Potassium Chloride Crystal Optic Rectangle, 30mm X 15mm X 4mm, Unpolished

289. Potassium Chloride Crystal Optic Rectangle, 41mm X 23mm X 6mm, Unpolished

290. Potassium Chloride Solution, Bioultra, For Molecular Biology, ~1 M In H2o

291. Potassium Chloride, Anhydrous, Beads, -10 Mesh, 99.99% Trace Metals Basis

292. Potassium Chloride, Nist Srm 1655, Kcl (cr) For Solution Calorimetry

293. Potassium Chloride, United States Pharmacopeia (usp) Reference Standard

294. Potassium Chloride Crystal Optic Disc, 32mm X 3mm (drilled), Polished Both Sides

295. Potassium Chloride Crystal Optic Rectangle, 30mm X 15mm X 4mm, Polished Both Sides

296. Potassium Chloride Crystal Optic Rectangle, 38.5mm X 19.5mm X 4mm, Unpolished

297. Potassium Chloride Solution, 0.075 M, Sterile-filtered, Bioxtra, Suitable For Cell Culture

298. Potassium Chloride Solution, Conductance Standard A Acc. To Iso 7888, 0.1 M Kcl

299. Potassium Chloride Solution, Conductance Standard B Acc. To Iso 7888, 0.01 M Kcl

300. Potassium Chloride Solution, Conductance Standard C Acc. To Iso 7888, 0.001 M Kcl

301. Potassium Chloride Solution, Conductivity 11.67 Ms/cm At 20 C, Analytical Standard

302. Potassium Chloride, Anhydrous, Beads, -10 Mesh, 99.999% Trace Metals Basis

303. Potassium Chloride, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99%

304. Potassium Chloride, Anhydrous, Free-flowing, Redi-dri(tm), Reagentplus(r), >=99%

305. Potassium Chloride, Pharmaceutical Secondary Standard; Certified Reference Material

306. Potassium Chloride, Puriss. P.a., Reag. Iso, Reag. Ph. Eur., 99.5-100.5%

307. Potassium Atomic Spectroscopy Standard Concentrate 1.00 G K, For 1 L Standard Solution, 1.00 G/l, Analytical Standard

308. Potassium Atomic Spectroscopy Standard Concentrate 10.00 G K, 10.00 G/l, For 1l Standard Solution, Analytical Standard

309. Potassium Chloride Crystal Optic Rectangle, 30mm X 15mm X 4mm, (drilled), Polished Both Sides

310. Potassium Chloride Crystal Optic Rectangle, 38.5mm X 19.5mm X 4mm, (drilled), Polished Both Sides

311. Potassium Chloride, Powder, Bioreagent, Suitable For Cell Culture, Suitable For Insect Cell Culture, >=99.0%

312. Potassium Chloride, Puriss., Meets Analytical Specification Of Ph. Eur., Bp, Usp, Fcc, E508, 99-100.5% (at), <=0.0001% Al

313. Potassium Standard Solution, Suitable For Atomic Absorption Spectrometry, 1000 Ppm K+, 1 Mg/ml K+

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 74.55 g/mol
Molecular Formula ClK
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass73.9325592 g/mol
Monoisotopic Mass73.9325592 g/mol
Topological Polar Surface Area0 Ų
Heavy Atom Count2
Formal Charge0
Complexity2
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 26  
Drug NameKlor-con
PubMed HealthPotassium Chloride (By mouth)
Drug ClassesNutriceutical, Potassium Supplement
Drug LabelKlor-ConM20 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.Klor-ConM15 is an immediately dispersing ex...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength10meq; 8meq
Market StatusPrescription
CompanyUpsher-smith Labs

2 of 26  
Drug NameKlor-con m10
Drug LabelKlor-Con M20 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.Klor-Con M15 is an immediately dispers...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength10meq
Market StatusPrescription
CompanyUpsher Smith Labs

3 of 26  
Drug NameKlor-con m15
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength15meq
Market StatusPrescription
CompanyUpsher Smith Labs

4 of 26  
Drug NameKlor-con m20
Drug LabelMicro-K Extencaps Capsules and Micro-K 10 Extencaps Capsules are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride, USP, equivalent to 8 and 10 mEq of potassium, respectiv...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength20meq
Market StatusPrescription
CompanyUpsher Smith Labs

5 of 26  
Drug NameK-tab
PubMed HealthPotassium Chloride (By mouth)
Drug ClassesNutriceutical, Potassium Supplement
Drug LabelK-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 750 mg of potassium chloride, USP, equivalent to 10 mEq of potassium in a film-coated (not enteric-coated), wax matrix tablet. This formu...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength20meq; 10meq
Market StatusPrescription
CompanyAbbvie

6 of 26  
Drug NameMicro-k
Drug LabelMicro-K Extencaps Capsules and Micro-K 10 Extencaps Capsules are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride, USP, equivalent to 8 and 10 mEq of potassium, respectiv...
Active IngredientPotassium chloride
Dosage FormCapsule, extended release
RouteOral
Strength8meq
Market StatusPrescription
CompanyNesher Pharms

7 of 26  
Drug NameMicro-k 10
Drug LabelPotassium Chloride for Injection Concentrate, USP, is a sterile, nonpyrogenic, concentrated solution of potassium chloride, USP in water for injection administered by intravenous infusion only after dilution in a larger volume of fluid. They are prov...
Active IngredientPotassium chloride
Dosage FormCapsule, extended release
RouteOral
Strength10meq
Market StatusPrescription
CompanyNesher Pharms

8 of 26  
Drug NamePotassium chloride
Active IngredientPotassium chloride
Dosage FormTablet, extended release; Tablet; Injectable; Capsule, extended release
Routeoral; Injection; Oral
Strength10.0meq; 20meq; 3meq/ml; 8.0meq; 10meq; 8meq; 2meq/ml
Market StatusTentative Approval; Prescription
CompanyMylan Pharms; Anchen Pharms; Amneal Pharms; Hospira; Actavis Labs Fl; Eurand; Baxter Hlthcare; Paddock; Fresenius Kabi Usa; B Braun; Esi Lederle; Elan Pharm

9 of 26  
Drug NamePotassium chloride 10meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength14.9mg/ml; 746mg/100ml; 745mg/100ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

10 of 26  
Drug NamePotassium chloride 20meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength1.49gm/100ml; 29.8mg/ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

11 of 26  
Drug NamePotassium chloride 30meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength2.24gm/100ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

12 of 26  
Drug NamePotassium chloride 40meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength2.98gm/100ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

13 of 26  
Drug NamePotassium chloride in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength2meq/ml
Market StatusPrescription
CompanyFresenius Kabi Usa

14 of 26  
Drug NameKlor-con
PubMed HealthPotassium Chloride (By mouth)
Drug ClassesNutriceutical, Potassium Supplement
Drug LabelKlor-ConM20 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.Klor-ConM15 is an immediately dispersing ex...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength10meq; 8meq
Market StatusPrescription
CompanyUpsher-smith Labs

15 of 26  
Drug NameKlor-con m10
Drug LabelKlor-Con M20 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.Klor-Con M15 is an immediately dispers...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength10meq
Market StatusPrescription
CompanyUpsher Smith Labs

16 of 26  
Drug NameKlor-con m15
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength15meq
Market StatusPrescription
CompanyUpsher Smith Labs

17 of 26  
Drug NameKlor-con m20
Drug LabelMicro-K Extencaps Capsules and Micro-K 10 Extencaps Capsules are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride, USP, equivalent to 8 and 10 mEq of potassium, respectiv...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength20meq
Market StatusPrescription
CompanyUpsher Smith Labs

18 of 26  
Drug NameK-tab
PubMed HealthPotassium Chloride (By mouth)
Drug ClassesNutriceutical, Potassium Supplement
Drug LabelK-TAB (potassium chloride extended-release tablets) is a solid oral dosage form of potassium chloride containing 750 mg of potassium chloride, USP, equivalent to 10 mEq of potassium in a film-coated (not enteric-coated), wax matrix tablet. This formu...
Active IngredientPotassium chloride
Dosage FormTablet, extended release
RouteOral
Strength20meq; 10meq
Market StatusPrescription
CompanyAbbvie

19 of 26  
Drug NameMicro-k
Drug LabelMicro-K Extencaps Capsules and Micro-K 10 Extencaps Capsules are oral dosage forms of microencapsulated potassium chloride containing 600 and 750 mg, respectively, of potassium chloride, USP, equivalent to 8 and 10 mEq of potassium, respectiv...
Active IngredientPotassium chloride
Dosage FormCapsule, extended release
RouteOral
Strength8meq
Market StatusPrescription
CompanyNesher Pharms

20 of 26  
Drug NameMicro-k 10
Drug LabelPotassium Chloride for Injection Concentrate, USP, is a sterile, nonpyrogenic, concentrated solution of potassium chloride, USP in water for injection administered by intravenous infusion only after dilution in a larger volume of fluid. They are prov...
Active IngredientPotassium chloride
Dosage FormCapsule, extended release
RouteOral
Strength10meq
Market StatusPrescription
CompanyNesher Pharms

21 of 26  
Drug NamePotassium chloride
Active IngredientPotassium chloride
Dosage FormTablet, extended release; Tablet; Injectable; Capsule, extended release
Routeoral; Injection; Oral
Strength10.0meq; 20meq; 3meq/ml; 8.0meq; 10meq; 8meq; 2meq/ml
Market StatusTentative Approval; Prescription
CompanyMylan Pharms; Anchen Pharms; Amneal Pharms; Hospira; Actavis Labs Fl; Eurand; Baxter Hlthcare; Paddock; Fresenius Kabi Usa; B Braun; Esi Lederle; Elan Pharm

22 of 26  
Drug NamePotassium chloride 10meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength14.9mg/ml; 746mg/100ml; 745mg/100ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

23 of 26  
Drug NamePotassium chloride 20meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength1.49gm/100ml; 29.8mg/ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

24 of 26  
Drug NamePotassium chloride 30meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength2.24gm/100ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

25 of 26  
Drug NamePotassium chloride 40meq in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength2.98gm/100ml
Market StatusPrescription
CompanyHospira; Baxter Hlthcare

26 of 26  
Drug NamePotassium chloride in plastic container
Active IngredientPotassium chloride
Dosage FormInjectable
RouteInjection
Strength2meq/ml
Market StatusPrescription
CompanyFresenius Kabi Usa

4.2 Therapeutic Uses

The oral dose of 10% potassium chloride elixir (Kay Ciel) required to reverse thiazide-induced hypokalemia was determined in 15 patients with essential hypertension who were taking Esidrix (hydrochlorothiazide) in a dose of 50 mg. twice daily. Each patient had maintained a serum potassium concentration of at least 0.5 meq./l. less than duplicate control values (mean decreases, 0.62 meq./l.) for at least 2 months during therapy with hydrochlorothiazide, 50 mg. twice daily. Potassium chloride 10% elixir was administered in a total daily dose of 40 mg. with bimonthly increments to 60 mg., 80 mg. and 100 mg. while the thiazide administration was maintained. The serum potassium deficit was repleted to 75% in 12 of the 15 patients. In 8 of the 12, this was accomplished with 40 mg. potassium chloride daily, and in 4, with 60 mg. daily. The latter dose is recommended in patients with thiazide-induced hypokalemia.

Schwartz AB and Swartz CD; J. Am. Med. Assoc.; VOL 230 P702-704 (1974)


Thirty-six adult patients with cardiovascular disorders were enrolled in an open 12 week study to evaluate the efficacy, safety and patient acceptance of sustained-release potassium chloride (Klotrix; I) tablets, at a dosage of 1.8 g daily. These patients were on an established regimen of potassium wasting diuretics as part of their treatment for hypertension or arteriosclerotic heart disease, and all were receiving an oral potassium supplement. On the first day of the study, the previously used oral potassium supplement was discontinued and I substituted. Serum potassium levels remained normal and other laboratory parameters did not change significantly as a result of the changeover from the previous potassium supplement to I. However, side effects occurred less frequently with I, and while more than half the patients commented on the bad taste or bad aftertaste of their previous supplement, no such comments were recorded for I. Patient acceptance of I was high, and 87% of the patients who completed the study expressed a preference for I over their previous oral potassium supplement.

Tarpley EL and Cordano A; Curr Ther Res Clin Exp.; VOL 21 ISS P282-288 (1977).


Medication (vet): as oral or parenteral source of potassium... in cattle it has been successfully used iv for "creeper cows"...& in cases of debilitating diarrhea. 1% Level in feed reduces incidence of urolithiasis in lambs, & orally...for...feeder calves...as electrolyle source.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 472


Potassium chloride is of value for the relief of symptoms of hypokaliemic periodic paralysis, and the symptoms of Meniere's disease. Daily intake of potassium decreases the risk of stroke-associated mortality.

OECD; Screening Information Data Set (SIDS) Initial Assessment Report for SIDS Initial Assessment Meeting (SIAM) 13, Potassium Chloride (CAS 7447-40-7) (November 2001). Available from, as of March 23, 2015. https://www.inchem.org/pages/sids.html


For more Therapeutic Uses (Complete) data for POTASSIUM CHLORIDE (16 total), please visit the HSDB record page.


4.3 Drug Warning

The cardiac effects of hyperkalemia are principal toxic effects of potassium. They are mediated through changes in the intra/extracellular potassium ratio, which alters cardiac conduction. With no underlying conduction defects a transient increase in cardiac conduction occurs with potassium concentrations above 7 mmol/L, but a profound depression occurs when concentrations rise over 8.0 mmol/L. One of the effects of hyperkalemia is the depolarisation of cardiac muscle, which interferes with normal contractility. Potassium chloride exerts a direct irritant effect on the gastrointestinal mucosa.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


Local pain and inflammation may result from subcutaneous injection). Skin rash has rarely been reported with potassium preparations.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


The initial signs of poisoning are generally gastrointestinal: nausea, vomiting and diarrhea. These symptoms can develop into abdominal pain and eventually paralytic ileus. Gastrointestinal perforation after oral exposure can occur. Bleeding and perforation have been reported in patients receiving solid forms of potassium chloride.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


A number of neuromuscular effects can be seen, usually with potassium concentrations of 7.0 mmol/L or higher. General weakness and flaccidity precede ascending paralysis. Tremor, paresthesias, decreased vibration perception and proprioception can be seen, but the sensory function is usually intact. Dysarthria and dysphagia may occur.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


For more Drug Warnings (Complete) data for POTASSIUM CHLORIDE (8 total), please visit the HSDB record page.


4.4 Minimum/Potential Fatal Human Dose

3. 3= Moderately toxic: probably oral lethal dose (human) 0.5-5 g/kg, between 1 oz and 1 pint (or 1 lb) for 70 kg person (150 lb).

Gosselin, R.E., R.P. Smith, H.C. Hodge. Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984., p. II-124


4.5 Drug Indication

For use as an electrolyte replenisher and in the treatment of hypokalemia.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

The potassium ion is in the principle intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal and smooth muscle, and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primarily or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine. If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long-term diuretic therapy, supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels. In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients, potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Potassium Compounds [CS]; Potassium Salt [EPC]; Increased Large Intestinal Motility [PE]
5.3 ATC Code

A - Alimentary tract and metabolism

A12 - Mineral supplements

A12B - Potassium

A12BA - Potassium

A12BA01 - Potassium chloride


B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05X - I.v. solution additives

B05XA - Electrolyte solutions

B05XA01 - Potassium chloride


5.4 Absorption, Distribution and Excretion

Absorption

Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine.


Route of Elimination

Potassium is a normal dietary constituent and, under steady-state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake.


At steady state continuous excretion of potassium chloride in the urine and faeces equals the daily intake.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


Orally and intravenously administered potassium chloride reaches an equilibrium between the extracellular fluid and intracellular space.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


Almost all orally administered potassium chloride is absorbed. The peak level and its occurrence time after ingestion depend on the preparation administered.

International Programme on Chemical Safety (IPCS); Poisons Information Monograph: Potassium Chloride (PIM 430) (1992) Available from, as of November 15, 2006: https://www.inchem.org/documents/pims/pharm/potasscl.htm


About 90% of the ingested dose of potassium is absorbed by passive diffusion in the membrane of the upper intestine. Potassium is distributed to all tissues where it is the principal intracellular cation. Insulin, acid-base status, aldosterone, and adrenergic activity regulate cellular uptake of potassium. /potassium/

OECD; Screening Information Data Set (SIDS) Initial Assessment Report for SIDS Initial Assessment Meeting (SIAM) 13, Potassium Chloride (CAS 7447-40-7) (November 2001). Available from, as of March 23, 2015. https://www.inchem.org/pages/sids.html


For more Absorption, Distribution and Excretion (Complete) data for POTASSIUM CHLORIDE (8 total), please visit the HSDB record page.


5.5 Mechanism of Action

Supplemental potassium in the form of high potassium food or potassium chloride may be able to restore normal potassium levels.


K+ is the principal cation mediating the osmotic balance of the body fluids. In animals, the maintenance of normal cell volume and pressure depends on Na+ and K+ pumping. The K+/Na+ separation has allowed for evolution of reversible transmembrane electrical potentials essential for nerve and muscle action in animals, and both potassium and chloride are important in transmission of nerve impulses to the muscle fibers. /postasium/

OECD; Screening INformation Data Set (SIDS) Initial Assessment Report for SIDS Initial Assessment Meeting (SIAM) 13, Potassium Chloride (CAS 7447-40-7) (November 2001). Available from, as of March 23, 2015. https://www.inchem.org/pages/sids.html


The reported mutagenic effect of KCl most probably results from a disruption of osmotic balance of cells with a subsequent interference with chromosomal stability. This may result in the clastogenic effects (DNA breakage and chromosome structural instability) due to K+ effects on sequestering of Mg2+ ions required for normal maintenance of chromatin integrity. Other chemicals may also exert such effect (e.g. NaCl, sucrose).

OECD; Screening INformation Data Set (SIDS) Initial Assessment Report for SIDS Initial Assessment Meeting (SIAM) 13, Potassium Chloride (CAS 7447-40-7) (November 2001). Available from, as of March 23, 2015. https://www.inchem.org/pages/sids.html


Potassium and chloride is also important in the regulation of the acid-base balance of the body. Potassium is the principal base in tissues of blood cells, and Cl maintains electrochemical neutrality by anion exchange with bicarbonate (the chloride shift) in the CO2 transport in the blood red cells.

OECD; Screening INformation Data Set (SIDS) Initial Assessment Report for SIDS Initial Assessment Meeting (SIAM) 13, Potassium Chloride (CAS 7447-40-7) (November 2001). Available from, as of March 23, 2015. https://www.inchem.org/pages/sids.html


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Certificate Number : CEP 2003-263 - Rev 05

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Details:

USFDA approved generic version of potassium chloride oral solution, which s indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis.


Lead Product(s): Potassium Chloride

Therapeutic Area: Nephrology Brand Name: Potassium Chloride-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 18, 2022

Strides Pharma Science

01

BIO Partnering at JPM
Not Confirmed

Lead Product(s) : Potassium Chloride

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : USFDA approved generic version of potassium chloride oral solution, which s indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis.

Brand Name : Potassium Chloride-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 18, 2022

Strides Pharma Science

Details:

The Potassium Chloride product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride for Oral Solution USP, 20 mEq, of Pharma Research Software Solution, LLC.


Lead Product(s): Potassium Chloride

Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 15, 2021

Strides Pharma Science

02

BIO Partnering at JPM
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Lead Product(s) : Potassium Chloride

Therapeutic Area : Nutrition and Weight Loss

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : The Potassium Chloride product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride for Oral Solution USP, 20 mEq, of Pharma Research Software Solution, LLC.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 15, 2021

Strides Pharma Science

Details:

Generic version of Potassium Chloride for Oral Solution USP, 20 mEq has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).


Lead Product(s): Potassium Chloride

Therapeutic Area: Nephrology Brand Name: Potassium Chloride-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 28, 2022

Granules India

03

BIO Partnering at JPM
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Lead Product(s) : Potassium Chloride

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Generic version of Potassium Chloride for Oral Solution USP, 20 mEq has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).

Brand Name : Potassium Chloride-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 28, 2022

Granules India

Details:

Generic version of Potassium Chloride capsule USP, 8 &1 0 mEq has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).


Lead Product(s): Potassium Chloride

Therapeutic Area: Nephrology Brand Name: Micro-K-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2021

Granules India

04

BIO Partnering at JPM
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Lead Product(s) : Potassium Chloride

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Generic version of Potassium Chloride capsule USP, 8 &1 0 mEq has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).

Brand Name : Micro-K-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 17, 2021

Granules India

Details:

Generic version of Potassium Chloride for Oral Solution USP, 20 mEq has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).


Lead Product(s): Potassium Chloride

Therapeutic Area: Nephrology Brand Name: Potassium Chloride-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 01, 2021

Granules India

05

BIO Partnering at JPM
Not Confirmed

Lead Product(s) : Potassium Chloride

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Generic version of Potassium Chloride for Oral Solution USP, 20 mEq has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).

Brand Name : Potassium Chloride-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 01, 2021

Granules India

Details:

Generic version of Potassium Chloride tablets has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).


Lead Product(s): Potassium Chloride

Therapeutic Area: Nephrology Brand Name: K-Dur-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 22, 2020

Granules India

06

BIO Partnering at JPM
Not Confirmed

Lead Product(s) : Potassium Chloride

Therapeutic Area : Nephrology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Details : Generic version of Potassium Chloride tablets has been approved to prevent or to treat patients suffering with low blood levels of potassium (hypokalemia).

Brand Name : K-Dur-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 22, 2020

Granules India

Details:

Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use, which is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.


Lead Product(s): Potassium Chloride

Therapeutic Area: Nutrition and Weight Loss Brand Name: Potassium Chloride-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 15, 2023

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BIO Partnering at JPM
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Details : Potassium Chloride Injection is a sterile, nonpyrogenic, highly concentrated, ready-to-use, which is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

Brand Name : Potassium Chloride-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 15, 2023

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Details:

Enterade® (sodium chloride) advanced oncology formula (a plant-based amino acid beverage) helps in reducing adverse gastrointestinal side effects for patients undergoing cancer treatment.


Lead Product(s): Sodium Chloride,Potassium Chloride,Magnesium Chloride

Therapeutic Area: Gastroenterology Brand Name: Enterade

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 27, 2023

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08

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
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Details : Enterade® (sodium chloride) advanced oncology formula (a plant-based amino acid beverage) helps in reducing adverse gastrointestinal side effects for patients undergoing cancer treatment.

Brand Name : Enterade

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 27, 2023

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Details:

The macrogol in Movicol (sodium chloride) binds with water and retains it in the bowel. This allows the water to rehydrate and bulk the stool to trigger renewed colonic activity.


Lead Product(s): Sodium Chloride,Sodium Bicarbonate,Potassium Chloride

Therapeutic Area: Gastroenterology Brand Name: Movicol

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Goldman Sachs Asset Management

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Financing December 15, 2022

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Norgine

Netherlands
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Norgine

Netherlands
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Details : The macrogol in Movicol (sodium chloride) binds with water and retains it in the bowel. This allows the water to rehydrate and bulk the stool to trigger renewed colonic activity.

Brand Name : Movicol

Molecule Type : Small molecule

Upfront Cash : Undisclosed

December 15, 2022

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Details:

Nexus Pharmaceuticals has announced that it has received U.S. FDA approval for Potassium Chloride in Water for Injection in 10mEq/100mL, 10mEq/50mL, 20mEq/100mL, 40mEq/100mL and 20mEq/50mL Single-Dose IV bags.


Lead Product(s): Potassium Chloride

Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 28, 2021

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10

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : Nexus Pharmaceuticals has announced that it has received U.S. FDA approval for Potassium Chloride in Water for Injection in 10mEq/100mL, 10mEq/50mL, 20mEq/100mL, 40mEq/100mL and 20mEq/50mL Single-Dose IV bags.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Not Applicable

March 28, 2021

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FDA Orange Book

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01

ABBVIE

U.S.A
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BIO Partnering at JPM
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : K-TAB

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 18279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

02

ABBVIE

U.S.A
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BIO Partnering at JPM
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : K-TAB

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1988-08-01

Application Number : 18279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

03

ABBVIE

U.S.A
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BIO Partnering at JPM
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : K-TAB

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2013-11-25

Application Number : 18279

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

04

BRECKENRIDGE

U.S.A
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BIO Partnering at JPM
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ

Approval Date : 2020-08-21

Application Number : 213588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

05

BRECKENRIDGE

U.S.A
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BIO Partnering at JPM
Not Confirmed

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 20MEQ

Approval Date : 2020-08-21

Application Number : 213588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

06

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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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RLD : No

TE Code : AB

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ

Approval Date : 2015-12-08

Application Number : 205549

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

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Not Confirmed
  • fda
  • EDQM
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Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content Digital Content

RLD : No

TE Code :

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8MEQ

Approval Date : 2019-01-22

Application Number : 206881

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content Digital Content

RLD : No

TE Code :

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ

Approval Date : 2019-01-22

Application Number : 206881

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content Digital Content

RLD : No

TE Code :

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 10MEQ

Approval Date : 2019-06-17

Application Number : 210097

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content Digital Content

RLD : No

TE Code : AB2

POTASSIUM CHLORIDE

Brand Name : POTASSIUM CHLORIDE

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : 8MEQ

Approval Date : 2018-08-31

Application Number : 210733

RX/OTC/DISCN : RX

RLD : No

TE Code : AB2

Strides Pharma Science
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 16682

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DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 17608

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18238

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 8ME...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18238

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10ME...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18279

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20ME...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18279

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MEQ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MEQ **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18279

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;149...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;450MG/100ML

USFDA APPLICATION NUMBER - 18362

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;224...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;224MG/100ML;450MG/100ML

USFDA APPLICATION NUMBER - 18362

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;298...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;450MG/100ML

USFDA APPLICATION NUMBER - 18362

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;74....DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;450MG/100ML

USFDA APPLICATION NUMBER - 18362

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;149...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;225MG/100ML

USFDA APPLICATION NUMBER - 18365

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;298...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18365

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;74....DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18365

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DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.9...DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

USFDA APPLICATION NUMBER - 18469

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10ME...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MEQ

USFDA APPLICATION NUMBER - 19123

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MEQ

USFDA APPLICATION NUMBER - 19123

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DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30M...DOSAGE - SOLUTION;IRRIGATION - 20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 19416

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DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 19685

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DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 19685

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DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 19685

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DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5G...DOSAGE - INJECTABLE;INJECTION - 20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML

USFDA APPLICATION NUMBER - 19685

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;149...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;149MG/100ML;900MG/100ML

USFDA APPLICATION NUMBER - 19691

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;224...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;224MG/100ML;900MG/100ML

USFDA APPLICATION NUMBER - 19691

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;298...DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;298MG/100ML;900MG/100ML

USFDA APPLICATION NUMBER - 19691

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DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;74....DOSAGE - INJECTABLE;INJECTION - 5GM/100ML;74.5MG/100ML;900MG/100ML

USFDA APPLICATION NUMBER - 19691

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DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM...DOSAGE - FOR SOLUTION;ORAL - 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT

USFDA APPLICATION NUMBER - 19797

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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1440ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML;105MG/100ML;3.5GM/100ML (1920ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100...DOSAGE - EMULSION;INTRAVENOUS - 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (1540ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2053ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100...DOSAGE - EMULSION;INTRAVENOUS - 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9GM/100ML (2566ML)

USFDA APPLICATION NUMBER - 200656

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DOSAGE - INJECTABLE;INJECTION - 1.49GM/100ML

USFDA APPLICATION NUMBER - 20161

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DOSAGE - INJECTABLE;INJECTION - 14.9MG/ML

USFDA APPLICATION NUMBER - 20161

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DOSAGE - INJECTABLE;INJECTION - 2.24GM/100ML

USFDA APPLICATION NUMBER - 20161

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DOSAGE - INJECTABLE;INJECTION - 2.98GM/100ML

USFDA APPLICATION NUMBER - 20161

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DOSAGE - INJECTABLE;INJECTION - 29.8MG/ML

USFDA APPLICATION NUMBER - 20161

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DOSAGE - INJECTABLE;INJECTION - 745MG/100ML

USFDA APPLICATION NUMBER - 20161

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DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 207026

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DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3....DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 207026

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DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3M...DOSAGE - SOLUTION;IRRIGATION - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

USFDA APPLICATION NUMBER - 20742

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DOSAGE - FOR SOLUTION;ORAL - 10MEQ

USFDA APPLICATION NUMBER - 208019

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DOSAGE - FOR SOLUTION;ORAL - 20MEQ

USFDA APPLICATION NUMBER - 208019

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DOSAGE - FOR SOLUTION;ORAL - 40MEQ

USFDA APPLICATION NUMBER - 208019

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DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479G...DOSAGE - TABLET;ORAL - 0.225GM;0.188GM;1.479GM

USFDA APPLICATION NUMBER - 213135

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DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/...DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

USFDA APPLICATION NUMBER - 21703

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DOSAGE - INJECTABLE;INJECTION - 2MEQ/ML

USFDA APPLICATION NUMBER - 80205

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ABOUT THIS PAGE

K-Dur Manufacturers

A K-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of K-Dur, including repackagers and relabelers. The FDA regulates K-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. K-Dur API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of K-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

K-Dur Suppliers

A K-Dur supplier is an individual or a company that provides K-Dur active pharmaceutical ingredient (API) or K-Dur finished formulations upon request. The K-Dur suppliers may include K-Dur API manufacturers, exporters, distributors and traders.

click here to find a list of K-Dur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

K-Dur USDMF

A K-Dur DMF (Drug Master File) is a document detailing the whole manufacturing process of K-Dur active pharmaceutical ingredient (API) in detail. Different forms of K-Dur DMFs exist exist since differing nations have different regulations, such as K-Dur USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A K-Dur DMF submitted to regulatory agencies in the US is known as a USDMF. K-Dur USDMF includes data on K-Dur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The K-Dur USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of K-Dur suppliers with USDMF on PharmaCompass.

K-Dur JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The K-Dur Drug Master File in Japan (K-Dur JDMF) empowers K-Dur API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the K-Dur JDMF during the approval evaluation for pharmaceutical products. At the time of K-Dur JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of K-Dur suppliers with JDMF on PharmaCompass.

K-Dur KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a K-Dur Drug Master File in Korea (K-Dur KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of K-Dur. The MFDS reviews the K-Dur KDMF as part of the drug registration process and uses the information provided in the K-Dur KDMF to evaluate the safety and efficacy of the drug.

After submitting a K-Dur KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their K-Dur API can apply through the Korea Drug Master File (KDMF).

click here to find a list of K-Dur suppliers with KDMF on PharmaCompass.

K-Dur CEP

A K-Dur CEP of the European Pharmacopoeia monograph is often referred to as a K-Dur Certificate of Suitability (COS). The purpose of a K-Dur CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of K-Dur EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of K-Dur to their clients by showing that a K-Dur CEP has been issued for it. The manufacturer submits a K-Dur CEP (COS) as part of the market authorization procedure, and it takes on the role of a K-Dur CEP holder for the record. Additionally, the data presented in the K-Dur CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the K-Dur DMF.

A K-Dur CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. K-Dur CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of K-Dur suppliers with CEP (COS) on PharmaCompass.

K-Dur WC

A K-Dur written confirmation (K-Dur WC) is an official document issued by a regulatory agency to a K-Dur manufacturer, verifying that the manufacturing facility of a K-Dur active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting K-Dur APIs or K-Dur finished pharmaceutical products to another nation, regulatory agencies frequently require a K-Dur WC (written confirmation) as part of the regulatory process.

click here to find a list of K-Dur suppliers with Written Confirmation (WC) on PharmaCompass.

K-Dur NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing K-Dur as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for K-Dur API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture K-Dur as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain K-Dur and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a K-Dur NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of K-Dur suppliers with NDC on PharmaCompass.

K-Dur GMP

K-Dur Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of K-Dur GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right K-Dur GMP manufacturer or K-Dur GMP API supplier for your needs.

K-Dur CoA

A K-Dur CoA (Certificate of Analysis) is a formal document that attests to K-Dur's compliance with K-Dur specifications and serves as a tool for batch-level quality control.

K-Dur CoA mostly includes findings from lab analyses of a specific batch. For each K-Dur CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

K-Dur may be tested according to a variety of international standards, such as European Pharmacopoeia (K-Dur EP), K-Dur JP (Japanese Pharmacopeia) and the US Pharmacopoeia (K-Dur USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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