List of Drug Master Files (DMF) of Pseudoephedrine, (+)- Active Pharmaceutical Ingredient listed on PharmaCompass.com

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Chemistry

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Also known as: Pseudoephedrine hcl, 345-78-8, Otrinol, Rhinalair, Tussaphed, Novafed
Molecular Formula
C10H16ClNO
Molecular Weight
201.69  g/mol
InChI Key
BALXUFOVQVENIU-KXNXZCPBSA-N
FDA UNII
6V9V2RYJ8N

Pseudoephedrine Hydrochloride
A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.
1 2D Structure

Pseudoephedrine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,2S)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride
2.1.2 InChI
InChI=1S/C10H15NO.ClH/c1-8(11-2)10(12)9-6-4-3-5-7-9;/h3-8,10-12H,1-2H3;1H/t8-,10+;/m0./s1
2.1.3 InChI Key
BALXUFOVQVENIU-KXNXZCPBSA-N
2.1.4 Canonical SMILES
CC(C(C1=CC=CC=C1)O)NC.Cl
2.1.5 Isomeric SMILES
C[C@@H]([C@H](C1=CC=CC=C1)O)NC.Cl
2.2 Other Identifiers
2.2.1 UNII
6V9V2RYJ8N
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ephedrine Threo Isomer

2. Isoephedrine

3. Pseudoephedrine

4. Pseudoephedrine Hcl

5. Sudafed

6. Threo Isomer Of Ephedrine

2.3.2 Depositor-Supplied Synonyms

1. Pseudoephedrine Hcl

2. 345-78-8

3. Otrinol

4. Rhinalair

5. Tussaphed

6. Novafed

7. Sudafed

8. Sudomyl

9. First Sign

10. D-pseudoephedrine Hydrochloride

11. Besan

12. Sudafed Hydrochloride

13. (+)-pseudoephedrine Hydrochloride

14. Pseudophedrine Hydrochloride

15. Galsud

16. Efidac 24

17. 1s,2s-(+)-pseudoephedrine Hydrochloride

18. Nsc-33634

19. Nsc-106567

20. 6v9v2ryj8n

21. L(+)-pseudoephedrine Hydrochloride

22. Sinufed

23. Coadvil

24. Symptom 2

25. D-(alpha-(1-methylamino)ethyl)benzyl Alcohol Hydrochloride

26. Sudafed 12 Hour

27. Pseudoephedrine, (+)-

28. Pseudoephedrine, L-(+)-

29. Suphedrine

30. Nexafed

31. Dorcol

32. Histalet Syrup

33. L-(+)-pseudoephedrine Hydrochloride

34. Sun Mark Sinus

35. Deconsal Ii

36. Chebi:8604

37. Sudafed Liquid, Children's

38. Pediacare Decongestant Drops

39. Sudafed 24 Hour

40. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol Hydrochloride

41. Benzenemethanol, Hydrochloride, S-(r,r)-

42. Wln: Qyr & Y1 & M1 & Gh-l

43. Dimetapp Decongestant

44. Actifed Sinus Daytime

45. Cpdd 0050

46. Benzenemethanol, Hydrochloride, [s-(r*,r*)]-

47. Einecs 206-462-1

48. Pseudoephedrine Hydrochloride [usan]

49. Nsc 33634

50. Unii-6v9v2ryj8n

51. Nsc 106567

52. (1s,2s)-2-(methylamino)-1-phenylpropan-1-ol;hydrochloride

53. Topcare 12 Hour Decongestant

54. D-[.alpha.-(1-methylamino)ethyl]benzyl Alcohol Hydrochloride

55. Ornex And Maximum Strength Ornex

56. Sudafed (tn)

57. Galpseud

58. Pseudoephedrine, Hydrochloride, L-(+)-

59. Pseudoephedrine Hydrochloride [usan:usp]

60. Tylenol Sinus Medication, Maximum Strength

61. Isoephedrine Hydrochloride

62. Contac Day & Night Allergy Sinus Day Caplets

63. Psi-ephedrine Hydrochloride

64. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (s-(r*,r*))-

65. Ec 206-462-1

66. Schembl33285

67. Mls001304069

68. Spectrum1500516

69. Chembl1200724

70. Sine-off Maximum Strength No Drowsiness Formula Caplets

71. Dtxsid10889343

72. Hms1920n04

73. Pharmakon1600-01500516

74. Nsc33634

75. Pseudoephedrine Hydrochloride (usp)

76. Ccg-39241

77. Nsc106567

78. Nsc759616

79. Akos027383893

80. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, (s-(r*,r*))-, Hydrochloride

81. Nsc-759616

82. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride, (.alpha.s)-

83. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride, (alphas)-

84. Benzenemethanol, Alpha-(1-(methylamino)ethyl)-, Hydrochloride, (s-(theta,theta))-

85. Pseudoephedrine Hydrochloride [mi]

86. Smr000718787

87. (+)-pseudoephedrine Hydrochloride, >=98%

88. P1654

89. Pseudoephedrine Hydrochloride [mart.]

90. Pseudoephedrine Hydrochloride [vandf]

91. Pseudoephedrine Hydrochloride [usp-rs]

92. Pseudoephedrine Hydrochloride [who-dd]

93. D00485

94. 345p788

95. Pseudoephedrine Hydrochloride [orange Book]

96. Myfed Component Pseudoephedrine Hydrochloride

97. Pseudoephedrine Hydrochloride [ep Monograph]

98. Pseudoephedrine Hydrochloride [usp Monograph]

99. W-106727

100. Actahist Component Pseudoephedrine Hydrochloride

101. Actifed Component Pseudoephedrine Hydrochloride

102. Aleve-d Component Pseudoephedrine Hydrochloride

103. Allerfed Component Pseudoephedrine Hydrochloride

104. Corphed Component Pseudoephedrine Hydrochloride

105. Histafed Component Pseudoephedrine Hydrochloride

106. Isoclor Component Pseudoephedrine Hydrochloride

107. Pseudoephedrine Hydrochloride Component Of Myfed

108. Q27108108

109. Triphed Component Pseudoephedrine Hydrochloride

110. Zyrtec-d Component Pseudoephedrine Hydrochloride

111. Allegra-d Component Pseudoephedrine Hydrochloride

112. Bromfed-dm Component Pseudoephedrine Hydrochloride

113. Mucinex D Component Pseudoephedrine Hydrochloride

114. Pseudoephedrine Hydrochloride Component Of Actifed

115. Pseudoephedrine Hydrochloride Component Of Aleve-d

116. Pseudoephedrine Hydrochloride Component Of Corphed

117. Pseudoephedrine Hydrochloride Component Of Isoclor

118. Pseudoephedrine Hydrochloride Component Of Triphed

119. Semprex-d Component Pseudoephedrine Hydrochloride

120. Triacin-c Component Pseudoephedrine Hydrochloride

121. Trilitron Component Pseudoephedrine Hydrochloride

122. (+)-pseudoephedrine Hydrochloride, Sigma Reference Standard

123. Bromanate Dm Component Pseudoephedrine Hydrochloride

124. Dimetane-dx Component Pseudoephedrine Hydrochloride

125. Hycofenix Component Of Pseudoephedrine Hydrochloride

126. Pseudoephedrine Hydrochloride Component Of Actahist

127. Pseudoephedrine Hydrochloride Component Of Allegra-d

128. Pseudoephedrine Hydrochloride Component Of Allerfed

129. Pseudoephedrine Hydrochloride Component Of Bromfed-dm

130. Pseudoephedrine Hydrochloride Component Of Histafed

131. Pseudoephedrine Hydrochloride Component Of Hycofenix

132. Pseudoephedrine Hydrochloride Component Of Mucinex D

133. Pseudoephedrine Hydrochloride Component Of Semprex-d

134. Pseudoephedrine Hydrochloride Component Of Triacin-c

135. Pseudoephedrine Hydrochloride Component Of Trilitron

136. Pseudoephedrine Hydrochloride Component Of Zyrtec-d

137. Pseudoephedrine Hydrochloride; Threo-ephedrine Hydrochloride

138. Sine-aid Ib Component Pseudoephedrine Hydrochloride

139. (1s,2s)-2-(methylamino)-1-phenyl-1-propanol Hydrochloride

140. Codimal-l.a. 12 Component Pseudoephedrine Hydrochloride

141. Pseudoephedrine Hydrochloride Component Of Bromanate Dm

142. Pseudoephedrine Hydrochloride Component Of Dimetane-dx

143. Pseudoephedrine Hydrochloride Component Of Sine-aid Ib

144. Advil Allergy Sinus Component Pseudoephedrine Hydrochloride

145. Children's Advil Cold Component Pseudoephedrine Hydrochloride

146. Children's Motrin Cold Component Pseudoephedrine Hydrochloride

147. Pseudoephedrine Hydrochloride Component Of Advil Allergy Sinus

148. Pseudoephedrine Hydrochloride Component Of Codimal-l.a. 12

149. (+)-pseudoephedrine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

150. Pseudoephedrine Hydrochloride Component Of Children's Advil Cold

151. Pseudoephedrine Hydrochloride Component Of Children's Motrin Cold

152. Pseudoephedrine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

153. Benzenemethanol, .alpha.-[(1s)-1-(methylamino)ethyl]-, Hydrochloride (1:1), (.alpha.s)-

154. Benzenemethanol, Alpha-((1s)-1-(methylamino)ethyl)-, Hydrochloride (1:1), (alphas)-

155. Pseudoephedrine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

156. Pseudoephedrine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

157. Pseudoephedrine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 201.69 g/mol
Molecular Formula C10H16ClNO
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count2
Rotatable Bond Count3
Exact Mass201.0920418 g/mol
Monoisotopic Mass201.0920418 g/mol
Topological Polar Surface Area32.3 Ų
Heavy Atom Count13
Formal Charge0
Complexity121
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 6  
Drug NamePseudoephedrine hydrochloride
Drug LabelActive ingredient (in each 5 mL) Purpose Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant...
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyRanbaxy; Perrigo

2 of 6  
Drug NameSudafed 12 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyMcneil Cons

3 of 6  
Drug NameSudafed 24 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength240mg
Market StatusOver the Counter
CompanyMcneil Cons

4 of 6  
Drug NamePseudoephedrine hydrochloride
Drug LabelActive ingredient (in each 5 mL) Purpose Pseudoephedrine hydrochloride 15 mg .............. Nasal decongestant...
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyRanbaxy; Perrigo

5 of 6  
Drug NameSudafed 12 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength120mg
Market StatusOver the Counter
CompanyMcneil Cons

6 of 6  
Drug NameSudafed 24 hour
Active IngredientPseudoephedrine hydrochloride
Dosage FormTablet, extended release
RouteOral
Strength240mg
Market StatusOver the Counter
CompanyMcneil Cons

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Bronchodilator Agents

Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)


Nasal Decongestants

Drugs designed to treat inflammation of the nasal passages, generally the result of an infection (more often than not the common cold) or an allergy related condition, e.g., hay fever. The inflammation involves swelling of the mucous membrane that lines the nasal passages and results in inordinate mucus production. The primary class of nasal decongestants are vasoconstrictor agents. (From PharmAssist, The Family Guide to Health and Medicine, 1993) (See all compounds classified as Nasal Decongestants.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
alpha-Adrenergic Agonist [EPC]; Adrenergic alpha-Agonists [MoA]

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14-Jan-2021
30-Aug-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

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 200MG;30MG

USFDA APPLICATION NUMBER - 19771

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DOSAGE - CAPSULE;ORAL - 8MG;60MG

USFDA APPLICATION NUMBER - 19806

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 240MG

USFDA APPLICATION NUMBER - 20021

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

USFDA APPLICATION NUMBER - 20786

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DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AN...DOSAGE - CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

USFDA APPLICATION NUMBER - 21374

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DOSAGE - TABLET;ORAL - 2MG;200MG;30MG

USFDA APPLICATION NUMBER - 21441

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2G...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG

USFDA APPLICATION NUMBER - 21585

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG

USFDA APPLICATION NUMBER - 21585

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

USFDA APPLICATION NUMBER - 21704

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DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;...DOSAGE - SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML

USFDA APPLICATION NUMBER - 22279

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DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22439

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DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **F...DOSAGE - SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22442

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DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5...DOSAGE - SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

USFDA APPLICATION NUMBER - 88811

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Fillers, Diluents & Binders

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Coating Systems & Additives

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Direct Compression

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Disintegrants & Superdisintegrants

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Thickeners and Stabilizers

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Controlled & Modified Release

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Granulation

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Taste Masking

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Solubilizers

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Film Formers & Plasticizers

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Topical

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Parenteral

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Chewable & Orodispersible Aids

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Co-Processed Excipients

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API Stability Enhancers

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Emulsifying Agents

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Empty Capsules

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Rheology Modifiers

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Surfactant & Foaming Agents

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Vegetarian Capsules

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Soft Gelatin

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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REF. STANDARDS & IMPURITIES

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