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Chemistry

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Also known as: 22204-53-1, (s)-naproxen, Naprosyn, (+)-naproxen, Equiproxen, Naproxene
Molecular Formula
C14H14O3
Molecular Weight
230.26  g/mol
InChI Key
CMWTZPSULFXXJA-VIFPVBQESA-N
FDA UNII
57Y76R9ATQ

Naproxen
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
Naproxen is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of naproxen is as a Cyclooxygenase Inhibitor.
1 2D Structure

Naproxen

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-(6-methoxynaphthalen-2-yl)propanoic acid
2.1.2 InChI
InChI=1S/C14H14O3/c1-9(14(15)16)10-3-4-12-8-13(17-2)6-5-11(12)7-10/h3-9H,1-2H3,(H,15,16)/t9-/m0/s1
2.1.3 InChI Key
CMWTZPSULFXXJA-VIFPVBQESA-N
2.1.4 Canonical SMILES
CC(C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)O
2.1.5 Isomeric SMILES
C[C@@H](C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
57Y76R9ATQ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Aleve

2. Anaprox

3. Methoxypropiocin

4. Naprosin

5. Naprosyn

6. Naproxen Sodium

7. Naproxenate, Sodium

8. Proxen

9. Sodium Naproxenate

10. Sodium, Naproxen

11. Synflex

2.3.2 Depositor-Supplied Synonyms

1. 22204-53-1

2. (s)-naproxen

3. Naprosyn

4. (+)-naproxen

5. Equiproxen

6. Naproxene

7. (s)-2-(6-methoxynaphthalen-2-yl)propanoic Acid

8. Aleve

9. (s)-(+)-naproxen

10. (s)-(+)-2-(6-methoxy-2-naphthyl)propionic Acid

11. Laraflex

12. D-naproxen

13. Ec-naprosyn

14. Naproxenum

15. Calosen

16. Naprosyne

17. Naproxeno

18. Nycopren

19. Bonyl

20. Naixan

21. Reuxen

22. (2s)-2-(6-methoxynaphthalen-2-yl)propanoic Acid

23. Axer

24. (+)-(s)-naproxen

25. Naproxen(+)

26. Acusprain

27. Anexopen

28. Arthrisil

29. Artrixen

30. Artroxen

31. Bipronyl

32. Clinosyn

33. Danaprox

34. Flexipen

35. Leniartil

36. Novonaprox

37. Anaprox

38. Apronax

39. Artagen

40. Atiflan

41. Congex

42. Daprox

43. Genoxen

44. Lefaine

45. Nafasol

46. Nalyxan

47. Napflam

48. Napmel

49. Naposin

50. Napren

51. Naprius

52. Veradol

53. Fuxen

54. Naxen

55. Naxyn

56. Xenar

57. Dysmenalgit N

58. Apo-naproxen

59. Floginax

60. Rs-3540

61. (s)-2-(6-methoxy-2-naphthyl)propionic Acid

62. (+)-2-(6-methoxy-2-naphthyl)propionic Acid

63. (+)-2-(methoxy-2-naphthyl)-propionic Acid

64. (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid

65. Dysmenalgit

66. Diocodal

67. (s)-2-(6-methoxy-2-naphthyl)propanoic Acid

68. Prexan

69. Apo-napro-na

70. D-2-(6-methoxy-2-naphthyl)propionic Acid

71. (+)-2-(methoxy-2-naphthyl)-propionsaeure

72. (+)-(s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid

73. (s)-(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid

74. Proxen

75. Cg 3117

76. Chebi:7476

77. (2s)-2-(6-methoxy-2-naphthyl)propanoic Acid

78. Chembl154

79. Nsc-750183

80. Nsc-757239

81. 57y76r9atq

82. D-2-(6'-methoxy-2'-naphthyl)-propionsaeure

83. Pn400 Component Naproxen

84. Naprium

85. Naprux

86. Propionic Acid, 2-(6-methoxy-2-naphthyl)-, (+)-

87. Duk

88. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, (s)-

89. Headlon

90. Napratec

91. Naprontag

92. Narocin

93. Naxopren

94. Prafena

95. Priaxen

96. Pronaxen

97. Rheumaflex

98. Saritilron

99. Sinartrin

100. Soproxen

101. Sutolin

102. Tohexen

103. Traumox

104. Flexen

105. Napxen

106. Noflam

107. Patxen

108. Rahsen

109. Sinton

110. Sutony

111. Velsay

112. Vinsen

113. Narma

114. Roxen

115. Anax

116. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, (.alpha.s)-

117. Cas-22204-53-1

118. Flanax Forte

119. Napren E

120. Naprosyn Lle

121. Proxen Le

122. Naxen F

123. Proxen Lle

124. U-ritis

125. Naprosyn Lle Forte

126. (s)-2-(6-methoxy-naphthalen-2-yl)-propionic Acid

127. Naproxi 250

128. Naproxi 500

129. (s)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic Acid

130. Naxyn 250

131. Naxyn 500

132. Equiproxen (veterinary)

133. Naproxene [inn-french]

134. Naproxenum [inn-latin]

135. (+)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid

136. Naproxeno [inn-spanish]

137. 26159-31-9

138. Xenar-cr

139. Ccris 5265

140. Hsdb 3369

141. Einecs 244-838-7

142. Rs 3540

143. (s)-(+)-6-methoxy-alp.-methyl-2-naphthalene Acetic Acid

144. Unii-57y76r9atq

145. Naprolag

146. Naprosine

147. Naprosy

148. Panoxen

149. Proxine

150. Mnpa

151. Sr-01000075977

152. Dl Naproxen

153. Naprosyn (tn)

154. Naproxen,(s)

155. Nps

156. Prestwick_349

157. (+)-2-(methoxy-2-naphthyl)-propionsaeure [german]

158. Mfcd00010500

159. Naproxen [usan:usp:inn:ban:jan]

160. D-2-(6'-methoxy-2'-naphthyl)-propionsaeure [german]

161. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, (+)-

162. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, (s)-

163. Spectrum_000977

164. 4or0

165. 4po0

166. Naproxen [hsdb]

167. Naproxen [inci]

168. Naproxen [usan]

169. (s)-(+)-naproxene

170. Naproxen [inn]

171. Naproxen [jan]

172. Naproxen [mi]

173. Naproxen [vandf]

174. Prestwick0_000791

175. Prestwick1_000791

176. Prestwick2_000791

177. Spectrum2_001043

178. Spectrum3_000514

179. Spectrum4_000069

180. Spectrum5_001327

181. (+)naproxen

182. Naproxen [mart.]

183. Naproxen2-(6-methoxy-naphthalen-2-yl)-propionic Acid

184. Epitope Id:139974

185. Naproxen [usp-rs]

186. Naproxen [who-dd]

187. Upcmld-dp001

188. 2-(6-methoxy-naphthalen-2-yl)-propionic Acid(naproxen)

189. Ec 244-838-7

190. Schembl3046

191. Dsstox_cid_20686

192. Dsstox_rid_79542

193. Dsstox_gsid_40686

194. Lopac0_000792

195. Bspbio_002067

196. Kbiogr_000597

197. Kbioss_001457

198. Bidd:gt0062

199. Divk1c_000242

200. Naproxen [green Book]

201. Spectrum1500425

202. Naproxen (jp17/usp/inn)

203. Spbio_000966

204. Spbio_002861

205. Naproxen [orange Book]

206. Gtpl5230

207. Naproxen [ep Monograph]

208. Vimovo Component Naproxen

209. Dtxsid4040686

210. Naproxen [usp Monograph]

211. Upcmld-dp001:001

212. Cmwtzpsulfxxja-vifpvbqesa-

213. Hms500m04

214. Kbio1_000242

215. Kbio2_001457

216. Kbio2_004025

217. Kbio2_006593

218. Kbio3_001567

219. Naproxen 1.0 Mg/ml In Methanol

220. Ninds_000242

221. Hms1920p13

222. Hms2089n21

223. Hms2091h12

224. Hms3649m13

225. Hms3886c15

226. Pharmakon1600-01500425

227. Zinc105216

228. Act02593

229. Naproxen Component Of Vimovo

230. Tox21_301953

231. Bdbm50339185

232. Ccg-40130

233. Nsc750183

234. Nsc757239

235. Akos005267223

236. Ac-1363

237. Db00788

238. Me-0100

239. Nsc 750183

240. Nsc 757239

241. Sdccgsbi-0050769.p005

242. Idi1_000242

243. Naproxen 100 Microg/ml In Acetonitrile

244. Naproxen Solution 1.0 Mg/ml In Methanol

245. Ncgc00016759-01

246. Ncgc00016759-02

247. Ncgc00016759-03

248. Ncgc00016759-38

249. Ncgc00021127-01

250. Ncgc00161591-01

251. Ncgc00255562-01

252. Hy-15030

253. Naproxen, Meets Usp Testing Specifications

254. Sbi-0050769.p004

255. Am20060551

256. M1021

257. S5177

258. Naproxen, Vetranal(tm), Analytical Standard

259. (2s)-2-(6-methoxynaphth-2-yl)propanoic Acid

260. (s)-2-(6-methoxy-2-naphthyl)-propionic Acid

261. (s)-2-(6-methoxynaphthalen-2-yl)propanoicacid

262. 04n531

263. C01517

264. D00118

265. O10203

266. (2s)-2-(6-methoxy(2-naphthyl))propanoic Acid

267. Ab00052049-04

268. Ab00052049_05

269. (+)(s)2-(6-methoxy-2-naphthyl)-propionic Acid

270. 2-(6-methoxy-2-naphthyl)propanoic Acid , (+)-

271. Sr-01000003110

272. Q-201447

273. Q1215575

274. Sr-01000003110-5

275. Sr-01000075977-3

276. Sr-01000075977-4

277. (+)-6-methoxy-.alpha.-methyl-2-napthaleneacetic Acid

278. Brd-k59197931-001-02-9

279. Brd-k59197931-001-03-7

280. Brd-k59197931-236-09-6

281. Sr-01000075977-10

282. (+)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic Acid

283. (alphas)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid

284. (s)-(+)-2-(6-methoxy-naphthalen-2-yl)-propionic Acid

285. (s)-6-methoxy-.alpha.-methyl-2-naphthalene Acetic Acid

286. Naproxen, British Pharmacopoeia (bp) Reference Standard

287. Naproxen, European Pharmacopoeia (ep) Reference Standard

288. (s)-(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid, 98%

289. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, (+)-

290. Naproxen, United States Pharmacopeia (usp) Reference Standard

291. (+)-(s)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic Acid

292. Naproxen, Pharmaceutical Secondary Standard; Certified Reference Material

293. Naproxen Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

294. (s)-(+)-2-(6-methoxy-2-naphthyl)propionic Acid;(s)-(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid

295. 131991-52-1

296. D-naproxen; (2s)-2-(6-methoxynaphthalen-2-yl)propanoic Acid; (s)-6-methoxy-?-methyl-2-naphthaleneacetic Acid; D-2-(6-methoxy-2-naphthyl)propionic Acid

2.4 Create Date
2005-06-29
3 Chemical and Physical Properties
Molecular Weight 230.26 g/mol
Molecular Formula C14H14O3
XLogP33.3
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass230.094294304 g/mol
Monoisotopic Mass230.094294304 g/mol
Topological Polar Surface Area46.5 Ų
Heavy Atom Count17
Formal Charge0
Complexity277
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 10  
Drug NameAleve
PubMed HealthNaproxen (By mouth)
Drug ClassesAnalgesic, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Active IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 200mg base
Market StatusOver the Counter
CompanyBayer

2 of 10  
Drug NameEc-naprosyn
Drug LabelNaproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl...
Active IngredientNaproxen
Dosage FormTablet, delayed release
RouteOral
Strength375mg; 500mg
Market StatusPrescription
CompanyRoche Palo

3 of 10  
Drug NameNaprelan
Drug LabelNAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r...
Active IngredientNaproxen sodium
Dosage FormTablet, extended release
RouteOral
Strengtheq 750mg base; eq 500mg base; eq 375mg base
Market StatusPrescription
CompanyAlmatica Pharma

4 of 10  
Drug NameNaprosyn
Drug LabelNaproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl...
Active IngredientNaproxen
Dosage FormTablet; Suspension
RouteOral
Strength250mg; 375mg; 500mg; 25mg/ml
Market StatusPrescription
CompanyRoche Palo

5 of 10  
Drug NameNaproxen
Drug LabelNAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r...
Active IngredientNaproxen
Dosage FormTablet; Suspension; Tablet, delayed release
RouteOral
Strength250mg; 375mg; 500mg; 25mg/ml
Market StatusPrescription
CompanyMylan Pharms; Marksans Pharma; Teva; Sandoz; Invagen Pharms; Hikma Pharms; Roxane; Perrigo R And D; Glenmark Generics; Amneal Pharms Ny; Aurobindo Pharma Usa; Zydus Pharms Usa; Pliva; Mylan

6 of 10  
Drug NameAleve
PubMed HealthNaproxen (By mouth)
Drug ClassesAnalgesic, Antimigraine, Antirheumatic, Central Nervous System Agent, Musculoskeletal Agent
Active IngredientNaproxen sodium
Dosage FormTablet
RouteOral
Strengtheq 200mg base
Market StatusOver the Counter
CompanyBayer

7 of 10  
Drug NameEc-naprosyn
Drug LabelNaproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl...
Active IngredientNaproxen
Dosage FormTablet, delayed release
RouteOral
Strength375mg; 500mg
Market StatusPrescription
CompanyRoche Palo

8 of 10  
Drug NameNaprelan
Drug LabelNAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r...
Active IngredientNaproxen sodium
Dosage FormTablet, extended release
RouteOral
Strengtheq 750mg base; eq 500mg base; eq 375mg base
Market StatusPrescription
CompanyAlmatica Pharma

9 of 10  
Drug NameNaprosyn
Drug LabelNaproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs.The chemical names for naproxen and naproxen sodium are (S)-6-methoxy--methyl-2-naphthaleneacetic acid and (S)-6-methoxy--methyl...
Active IngredientNaproxen
Dosage FormTablet; Suspension
RouteOral
Strength250mg; 375mg; 500mg; 25mg/ml
Market StatusPrescription
CompanyRoche Palo

10 of 10  
Drug NameNaproxen
Drug LabelNAPRELAN* Tablets contain naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use the proprietary IPDAS** (Intestinal Protective Drug Absorption System) technology. It is a r...
Active IngredientNaproxen
Dosage FormTablet; Suspension; Tablet, delayed release
RouteOral
Strength250mg; 375mg; 500mg; 25mg/ml
Market StatusPrescription
CompanyMylan Pharms; Marksans Pharma; Teva; Sandoz; Invagen Pharms; Hikma Pharms; Roxane; Perrigo R And D; Glenmark Generics; Amneal Pharms Ny; Aurobindo Pharma Usa; Zydus Pharms Usa; Pliva; Mylan

4.2 Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Gout Suppressants

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Naproxen and its salt are used to relieve postoperative pain (including that associated with dental surgery), postpartum pain, primary dysmenorrhea, pain following insertion of an intrauterine contraceptive device, orthopedic pain, headache (including migraine), and visceral pain associated with cancer. Naproxen sodium also may be used for self-medication to provide temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, and backache. /Included in US product label/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2164


Naproxen has been used in the symptomatic management of osteitis deformans (Paget's disease of bone) and Bartter's syndrome. /Use is not currently included in the labeling approved by the US FDA/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2164


When used in the treatment of rheumatoid arthritis or juvenile rheumatoid arthritis, naproxen has relieved pain and stiffness, reduced swelling, and improved mobility and grip strength. In the treatment of osteoarthritis, naproxen has relieved pain and stiffness and improved knee joint function. Naproxen appears to be only palliative in these conditions and has not been shown to permanently arrest or reverse the underlying disease process. Naproxen sodium also may be used for self-medication to provide temporary relief of minor aches and pains associated with arthritis. /Included in US product label/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2164


For more Therapeutic Uses (Complete) data for NAPROXEN (9 total), please visit the HSDB record page.


4.3 Drug Warning

Pseudoporphyria is characterized by skin fragility, blistering and scarring in sun-exposed skin areas without abnormalities in porphyrin metabolism. The phenylpropionic acid derivative group of nonsteroidal anti-inflammatory drugs, especially naproxen, is known to cause pseudoporphyria. Naproxen is currently one of the most prescribed drugs in the therapy of juvenile idiopathic arthritis. The prevalence of pseudoporphyria was determined in a 9-year retrospective study of children with juvenile idiopathic arthritis and associated diseases. In addition, /the investigators/ prospectively studied the incidence of pseudoporphyria in 196 patients (127 girls and 69 boys) with juvenile idiopathic arthritis and associated diseases treated with naproxen from July 2001 to March 2002. ... These data /were compared/ with those from a matched control group with juvenile idiopathic arthritis and associated diseases not treated with naproxen in order to identify risk factors for development of pseudoporphyria. The incidence of pseudoporphyria in the group of children taking naproxen was 11.4%. Pseudoporphyria was particularly frequent in children with the early-onset pauciarticular subtype of juvenile idiopathic arthritis (mean age 4.5 years). Pseudoporphyria was associated with signs of disease activity, such as reduced hemoglobin (<11.75 g/dL), and increased leucocyte counts (>10,400/uL) and erythocyte sedimentation rate (>26 mm/hour). Comedications, especially chloroquine intake, appeared to be additional risk factors. The mean duration of naproxen therapy before the onset of pseudoporphyria was 18.1 months, and most children with pseudoporphyria developed their lesions within the first 2 years of naproxen treatment. Juvenile idiopathic arthritis disease activity seems to be a confounding factor for pseudoporphyria. In particular, patients with early-onset pauciarticular juvenile idiopathic arthritis patients who have significant inflammation appear to be prone to developing pseudoporphyria upon treatment with naproxen.

PMID:17266758 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1860069 Schad SG et al; Arthritis Res Ther 9 (1): R10 (2007).


Short-term use of NSAIAs to relieve acute pain, especially at low dosages, does not appear to be associated with an increased risk of serious cardiovascular events (except immediately following coronary artery bypass graft (CABG) surgery). Therefore, in early 2005, the US Food and Drug Administration (FDA) concluded that preparations of NSAIAs (including naproxen) that currently were available without a prescription had a favorable benefit-to-risk ratio when used according to labeled instructions, and determined that these preparations should remain available without a prescription despite the addition of a boxed warning to the professional labeling of prescription-only preparations of these drugs.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2165


With the exception of precautions related to the sodium content of naproxen sodium, the cautions associated with naproxen sodium use are the same as those for naproxen use. Each 275 or 550 mg naproxen sodium tablet contains about 1 or 2 mEq of sodium, respectively, and each mL of the commercially available naproxen suspension contains about 0.34 mEq of sodium; this should be considered in patients whose sodium intake must be restricted. /Naproxen sodium/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2166


Patients should be advised that naproxen, like other nonsteroidal anti-inflammatory agents, is not free of potential adverse effects, including some that can cause discomfort, and that, rarely, more serious effects (e.g., GI bleeding), which may require hospitalization and may even be fatal, can occur. Patients also should be informed that, while nonsteroidal anti-inflammatory agents may be commonly employed for conditions that are less serious, nonsteroidal anti-inflammatory agent therapy often is considered essential for the management of some diseases (eg, rheumatoid arthritis), and the drugs have a major role in the management of pain. Clinicians may wish to discuss with their patients the potential risks and likely benefits of nonsteroidal anti-inflammatory agent therapy, particularly when consideration is being given to use of these drugs in less serious conditions for which therapy without a nonsteroidal anti-inflammatory agent may represent an acceptable alternative to both the patient and clinician.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2166-7


For more Drug Warnings (Complete) data for NAPROXEN (40 total), please visit the HSDB record page.


4.4 Drug Indication

Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain. Further, it is first-line therapy for osteoarthritis, acute gouty arthritis, dysmenorrhea, and musculoskeletal inflammation and pain.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Naproxen is an established non-selective NSAID and is useful as an analgesic, anti-inflammatory and antipyretic. Similar to other NSAIDs, the pharmacological activity of naproxen can be attributed to the inhibition of cyclo-oxygenase, which in turn reduces prostaglandin synthesis in various tissues and fluids including the synovial fluid, gastric mucosa, and the blood. Although naproxen is an effective analgesic, it can have unintended deleterious effects in the patient. For instance, naproxen can adversely affect blood pressure control. A study found that use of naproxen induced an increase in blood pressure, although the increase was not as significant as that found with ibuprofen use. Further, studies have found that the risk of upper gastrointestinal bleeding is on average four-fold higher for individuals taking NSAIDs. Other factors that increase the risk of upper gastrointestinal bleeding include concurrent use of corticosteroids or anticoagulants, and a history of gastrointestinal ulcers.


5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents, Non-Steroidal

Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)


Cyclooxygenase Inhibitors

Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)


Gout Suppressants

Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout. (See all compounds classified as Gout Suppressants.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
NAPROXEN
5.3.2 FDA UNII
57Y76R9ATQ
5.3.3 Pharmacological Classes
Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]
5.4 ATC Code

M01AE02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


G - Genito urinary system and sex hormones

G02 - Other gynecologicals

G02C - Other gynecologicals

G02CC - Antiinflammatory products for vaginal administration

G02CC02 - Naproxen


M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01A - Antiinflammatory and antirheumatic products, non-steroids

M01AE - Propionic acid derivatives

M01AE02 - Naproxen


M - Musculo-skeletal system

M02 - Topical products for joint and muscular pain

M02A - Topical products for joint and muscular pain

M02AA - Antiinflammatory preparations, non-steroids for topical use

M02AA12 - Naproxen


5.5 Absorption, Distribution and Excretion

Absorption

Naproxen is available as a free acid and sodium salt. At comparable doses, (naproxen 500 mg = naproxen sodium 550 mg) they differ slightly in their rates of absorption, but otherwise they are therapeutically and pharmacologically equivalent. Naproxen sodium achieves a peak plasma concentration after 1 hour, while peak plasma concentration is observed after 2 hours with naproxen (free acid). There are no differences between the 2 forms in the post-absorption phase pharmacokinetics. The difference in initial absorption should be considered when treating acute pain, since naproxen sodium may offer a quicker onset of action. The mean Cmax for the various formulations (immediate release, enteric coated, controlled release etc.) of naproxen are comparable and range from 94 mcg/mL to 97.4 mcg/mL. In one pharmacokinetic study, the mean Tmax of naproxen 500 mg (immediate release) given every 12 hours over 5 days was 3 hours, compared to a mean Tmax of 5 hours for Naprelan 1000 mg (controlled release) given every 24 hours over 5 days. In this same study, the AUC0-24hr was 1446mcgxhr/mL for naproxen immediate release and 1448 mcgxhr/mL for the controlled release formulation. A separate study comparing the pharmacokinetics of Naprosyn tablets and EC-Naprosyn observed the following values: Tmax and AUC0-12hrs of EC-Naprosyn were 4 hours and 845 mcgxhr/mL respectively, and Tmax and AUC0-12hrs values of Naprosyn were 1.9 hours and 767 mcgxhr/mL respectively. When given in combination with sumatriptan the Cmax of naproxen is roughly 36% lower compared to naproxen sodium 550 mg tablets, and the median Tmax is 5 hours. Based on the AUC and Cmax of naproxen, Vimovo (naproxen/esomeprazole combination product) and enteric-coated naproxen may be considered bioequivalent. Overall, naproxen is rapidly and completely absorbed when administered orally and rectally. Food may contribute to a delay in the absorption of orally administered naproxen, but will not affect the extent of absorption.


Route of Elimination

After oral administration, about 95% of naproxen and it's metabolites can be recovered in the urine with 66-92% recovered as conjugated metabolite and less than 1% recovered as naproxen or desmethylnaproxen. Less than 5% of naproxen is excreted in the feces.


Volume of Distribution

Naproxen has a volume of distribution of 0.16 L/kg.


Clearance

Naproxen is cleared at a rate of 0.13 mL/min/kg.


Oral absorption of naproxen in dogs is rapid, with peak plasma concentration reached in 0.5-3 hr. The reported elimination half-life in dogs is 34-72 hr. Naproxen is highly protein bound (>99.0%). In dogs, naproxen is primarily eliminated through the bile, whereas in other species, the primary route of elimination is through the kidneys. The long half-life of naproxen in dogs appears to be due to its extensive enterohepatic recirculation.

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 2528


After therapeutic doses, naproxen is more than 99% bound to plasma proteins. When naproxen binding sites become saturated (at twice daily doses of 500 mg or more), plasma free drug concentrations increase and may result in increased urinary clearance rates. Therefore, plasma naproxen concentrations tend to plateau when dosage exceeds 500 mg twice daily. In a study in patients with severe renal failure, binding of naproxen to serum proteins was decreased compared to healthy adults; the decreased binding may have accounted for an increase in metabolism and apparent volume of distribution of the drug observed in these patients. In patients with chronic alcoholic liver disease, total plasma concentrations of naproxen are decreased while concentrations of the unbound drug are increased.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2170


The pharmacokinetics of naproxen, its metabolite 6-hydroxy-alpha-methyl-2-naphthaleneacetic acid (O-desmethylnaproxen), and their acyl glucuronides were studied in 10 subjects (ages 20-50 yr) who received an oral dose of 500 mg naproxen. Mean half-life of naproxen in 9 subjects was 24.7 hr. A half-life of 7.4 hr in the 10th subject was considered an extraordinary case. Naproxen acyl glucuronide accounted for 50.8% of the dose, its isomerized conjugate isoglucuronide for 6.5%, O-desmethylnaproxen acyl glucuronide for 14.3%, and its isoglucuronide for 5.5%. Excretion of naproxen and O-desmethylnaproxen was negligible. Plasma protein binding was 98% for naproxen, 100% for O-desmethylnaproxen, 92% for naproxen acyl glucuronide, 66% for naproxen isoglucuronide, 72% for O-desmethylnaproxen acyl glucuronide, and 42% for O-desmethylnaproxen isoglucuronide. It was concluded that naproxen is O-desmethylated and parent drug and metabolite are conjugated into acyl glucuronides.

PMID:8218967 Vree TB et al; Biopharm Drug Dispos 14 (8): 491-502 (1993)


The effects of rheumatoid arthritis disease activity on the pharmacokinetics of the highly albumin-bound nonsteroidal anti-inflammatory drug naproxen were studied in six patients during chronic therapy. In the same patients, kinetics during active disease were compared with those in improvement. Active disease is commonly associated with hypoalbuminemia: 30 +/- 4 gm/L vs. 41 +/- 2 gm/L (mean +/- SD) at the time of improvement. Total naproxen concentrations were significantly lower in active disease, together with a larger apparent volume of distribution (10.6 +/- 1.8 L vs. 8.4 +/- 1.3 L; P less than 0.05) and total body clearance (0.79 +/- 1.8 L/hr vs. 0.59 +/- 0.14 L/hr; P less than 0.001). Peak unbound naproxen concentrations were 29% +/- 19% (P less than 0.05) lower at the time of improvement. The unbound clearance was found diminished during active disease (390 +/- 277 L/hr) in comparison with improvement (488 +/- 343 L/hr; P less than 0.05). Clinical implications of the alterations in naproxen kinetics induced by polyarticular inflammation in patients with rheumatoid arthritis are discussed.

PMID:3335121 Van den Ouweland FA et al; Clin Pharmacol Ther 43 (1): 79-85 (1988).


For more Absorption, Distribution and Excretion (Complete) data for NAPROXEN (15 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Naproxen is heavily metabolized in the liver and undergoes both Phase I and Phase II metabolism. The first step involves demethylation of naproxen via CYP 1A2, 2C8, and 2C9. Both naproxen and desmethylnaproxen proceed to Phase II metabolism; however, desmethylnaproxen can form both acyl and phenolic glucoronide products, while naproxen only produces the acyl glucuronide. The acyl glucuronidation process involves UGT 1A1, 1A3, 1A6, 1A7, 1A9, 1A10 and 2B7, while phenolic glucuronidation is catalyzed by UGT 1A1, 1A7,1A9, and 1A10. Desmethylnaproxen also undergoes sulphation which is mediated by SULT 1A1, 1B1 and 1E1.


Naproxen is extensively metabolized in the liver to 6-desmethylnaproxen. Approximately 95% of the drug is excreted in urine as unchanged naproxen (less than 1%) and 6-desmethylnaproxen (less than 1%) and their glucuronide or other conjugates (66-92%). Some data suggest that renal excretion of unchanged naproxen may be negligible or absent; previously reported concentrations of unchanged drug may reflect rapid hydrolysis of conjugates during collection, storage, and handling of urine samples. The half-life of naproxen metabolites and conjugates is shorter than 12 hours. Naproxen metabolites may accumulate in patients with renal impairment. Elimination of naproxen is reduced in patients with severe renal impairment. A small amount (less than 5%) of the drug is excreted in feces.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2170


The pharmacokinetics of naproxen, its metabolite 6-hydroxy-alpha-methyl-2-naphthaleneacetic acid (O-desmethylnaproxen), and their acyl glucuronides were studied in 10 subjects (ages 20-50 yr) who received an oral dose of 500 mg naproxen. Mean half-life of naproxen in 9 subjects was 24.7 h. A half-life of 7.4 h in the 10th subject was considered an extraordinary case. Naproxen acyl glucuronide accounted for 50.8% of the dose, its isomerized conjugate isoglucuronide for 6.5%, O-desmethylnaproxen acyl glucuronide for 14.3%, and its isoglucuronide for 5.5%. Excretion of naproxen and O-desmethylnaproxen was negligible. Plasma protein binding was 98% for naproxen, 100% for O-desmethylnaproxen, 92% for naproxen acyl glucuronide, 66% for naproxen isoglucuronide, 72% for O-desmethylnaproxen acyl glucuronide, and 42% for O-desmethylnaproxen isoglucuronide. It was concluded that naproxen is O-desmethylated and parent drug and metabolite are conjugated into acyl glucuronides.

PMID:8218967 Vree TB et al; Biopharm Drug Dispos 14 (8): 491-502 (1993)


Naproxen has known human metabolites that include (2S,3S,4S,5R)-3,4,5-Trihydroxy-6-[(2S)-2-(6-methoxynaphthalen-2-yl)propanoyl]oxyoxane-2-carboxylic acid and O-Desmethylnaproxen.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

The elimination half-life of naproxen is reported to be 12-17 hours.


The reported elimination half-life in dogs is 34-72 hr.

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 2528


In healthy adults, the plasma half-life of naproxen reportedly ranges from 10-20 hr. The manufacturer state that the plasma half-life of naproxen is about 13 hr. The plasma half-life and elimination of the drug appear to be similar in children and adults.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2170


The pharmacokinetics of naproxen, its metabolite 6-hydroxy-alpha-methyl-2-naphthaleneacetic acid (O-desmethylnaproxen), and their acyl glucuronides were studied in 10 subjects (ages 20-50 yr) who received an oral dose of 500 mg naproxen. Mean half-life of naproxen in 9 subjects was 24.7 hr. A half-life of 7.4 hr in the 10th subject was considered an extraordinary case. ...

PMID:8218967 Vree TB et al; Biopharm Drug Dispos 14 (8): 491-502 (1993)


5.8 Mechanism of Action

As with other non-selective NSAIDs, naproxen exerts it's clinical effects by blocking COX-1 and COX-2 enzymes leading to decreased prostaglandin synthesis. Although both enzymes contribute to prostaglandin production, they have unique functional differences. The COX-1 enzymes is constitutively active and can be found in normal tissues such as the stomach lining, while the COX-2 enzyme is inducible and produces prostaglandins that mediate pain, fever and inflammation. The COX-2 enzyme mediates the desired antipyretic, analgesic and anti-inflammatory properties offered by Naproxen, while undesired adverse effects such as gastrointestinal upset and renal toxicities are linked to the COX-1 enzyme.


Naproxen has pharmacologic actions similar to those of other prototypical nonsteroidal anti-inflammatory agents (NSAIAs). The drug exhibits anti-inflammatory, analgesic, and antipyretic activity. The exact mechanisms have not been clearly established, but many of the actions appear to be associated principally with the inhibition of prostaglandin synthesis. Naproxen inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2) (also referred to as prostaglandin G/H synthase-1 (PGHS-1) and -2 (PGHS-2), respectively), have been identified that catalyze the formation of prostaglandins in the arachidonic acid pathway. Naproxen, like other prototypical NSAIAs, inhibits both COX-1 and COX-2. Although the exact mechanisms have not been clearly established, NSAIAs appear to exert anti-inflammatory, analgesic, and antipyretic activity principally through inhibition of the COX-2 isoenzyme; COX-1 inhibition presumably is responsible for the drugs' unwanted effects on GI mucosa and platelet aggregation.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2169


The anti-inflammatory, analgesic, and antipyretic effects of naproxen and other nonsteroidal anti-inflammatory agents (NSAIAs), including selective inhibitors of COX-2 (e.g., celecoxib, rofecoxib), appear to result from inhibition of prostaglandin synthesis. While the precise mechanism of the anti-inflammatory and analgesic effects of NSAIAs continues to be investigated, these effects appear to be mediated principally through inhibition of the COX-2 isoenzyme at sites of inflammation with subsequent reduction in the synthesis of certain prostaglandins from their arachidonic acid precursors. Naproxen stabilizes lysosomal membranes and inhibits the response of neutrophils to chemotactic stimuli. The drug does not possess glucocorticoid or adrenocorticoid-stimulating properties.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2169


Naproxen lowers body temperature in patients with fever. Although the mechanism of the antipyretic effect of nonsteroidal anti-inflammatory agents is not known, it has been suggested that suppression of prostaglandin synthesis in the CNS (probably in the hypothalamus) may be involved.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2169


Naproxen-induced inhibition of prostaglandin synthesis may result in decreased frequency and intensity of uterine contractility. Prostaglandins E2 and F2alpha increase the amplitude and frequency of uterine contractions in pregnant women; current evidence suggests that primary dysmenorrhea is also mediated by these prostaglandins. Whether the increased production of prostaglandins associated with primary dysmenorrhea is mediated by COX-1 or COX-2 remains to be determined. Blood concentrations of a metabolite of prostaglandin F2alpha have been found to decrease in women with dysmenorrhea who were receiving naproxen. Therapy with naproxen has been effective in relieving menstrual pain and has reduced blood loss in women with menorrhagia, probably by inhibiting the formation of these prostaglandins. Administration of naproxen during late pregnancy may prolong gestation by inhibiting uterine contractions.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2169


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CIVAC C.P.62578 JIUT EPEC, MORELOS, Cuautla Morelos, , M Mexico","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725820200,"product":"NAPROXEN SODIUM-USP (W.G:30.48KGS, PKG:1 DRUM)","address":"D4, PHASE V, I.D.A., JEEDIMETLA,","city":"ANDHRA PRADESH","supplier":"DIVIS LABORATORIES LIMITED-SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DLL SEZ","customer":"SAI PARENTERAL'S LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"39.3","totalValueFC":"996.4","currency":"USD","unitRateINR":"3340","date":"09-Sep-2024","totalValueINR":"83500","totalValueInUsd":"996.4","indian_port":"Vizag-DLL SEZ","hs_no":"29189990","bill_no":"5494848","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DLL SEZ","supplierAddress":"CHIPPADA VILLAGE ANNAVARAM POST BHEEMUNIPATNAM MANDAL VISAKHAPATNAM SDNF India","customerAddress":"D4, PHASE V, I.D.A., JEEDIMETLA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726770600,"product":"NAPROXEN IP\/BP","address":"202, SAI PLAZA, SANT NAGAR","city":"NEW DELHI","supplier":"DIVIS LABORATORIES LIMITED-DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PRETTY PETALS PRIVATE ","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"27.1","totalValueFC":"27445.9","currency":"USD","unitRateINR":"2300","date":"20-Sep-2024","totalValueINR":"2300000","totalValueInUsd":"27445.9","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29189990","bill_no":"5695526","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF India","customerAddress":"202, SAI PLAZA, SANT NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"NAPROXEN SODIUM USP","address":"CEAT MAHAL, 463, ANNIE BESANT ROAD,","city":"MUMBAI, MAHARASHTRA","supplier":"DIVIS LABORATORIES LIMITED-SEZ UNIT","supplierCountry":"INDIA","foreign_port":"DLL SEZ","customer":"RPG LIFE SCIENCES LTD.","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"28.4","totalValueFC":"143196","currency":"USD","unitRateINR":"2400","date":"25-Sep-2024","totalValueINR":"12000000","totalValueInUsd":"143196","indian_port":"Vizag-DLL SEZ","hs_no":"29189990","bill_no":"5792081","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DLL SEZ","supplierAddress":"CHIPPADA VILLAGE ANNAVARAM POST BHEEMUNIPATNAM MANDAL VISAKHAPATNAM SDNF India","customerAddress":"CEAT MAHAL, 463, ANNIE BESANT ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727202600,"product":"NAPROXEN IP\/USP","address":"202, SAI PLAZA, SANT NAGAR","city":"NEW DELHI","supplier":"M\/S.DIVIS LABORATORIES LIMITED,-DC SEZ","supplierCountry":"INDIA","foreign_port":"LINGOJUGUDEM","customer":"PRETTY PETALS PRIVATE ","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"27.2","totalValueFC":"27445.9","currency":"USD","unitRateINR":"2300","date":"25-Sep-2024","totalValueINR":"2300000","totalValueInUsd":"27445.9","indian_port":"DC-SEZ Unit at Choutuppal Telangana","hs_no":"29189990","bill_no":"5783892","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LINGOJUGUDEM","supplierAddress":"LINGOJIGUDEM VILLAGE CHOUTUPPAL MANDAL YADADRI-BHUVANAGIRI(DT) SDNF India","customerAddress":"202, SAI PLAZA, SANT NAGAR"}]
06-Jan-2021
30-Sep-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 250MG

USFDA APPLICATION NUMBER - 17581

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DOSAGE - TABLET;ORAL - 375MG

USFDA APPLICATION NUMBER - 17581

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DOSAGE - TABLET;ORAL - 500MG

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - 375MG

USFDA APPLICATION NUMBER - 20067

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - 500MG

USFDA APPLICATION NUMBER - 20067

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22511

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DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20...DOSAGE - TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22511

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