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29 API Suppliers, 22 USDMF, 7 CEP/COS, 4 EU WC, 34 KDMF, 11 NDC API, 9 Listed Suppliers, $ API Reference Price

29 API Suppliers
22 USDMF
7 CEP/COS
4 EU WC
34 KDMF
11 NDC API
9 Listed Suppliers
$ API Reference Price

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6 Drugs in Development

6 Drugs in Development

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148 FDF Dossiers, 85 FDA Orange Book, 11 Europe, 18 Canada, 4 South Africa, 30 Listed Dossiers

148 FDF Dossiers
85 FDA Orange Book
11 Europe
18 Canada
4 South Africa
30 Listed Dossiers

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TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 500MG BASE, TABLET;ORAL - 220MG, TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE, CAPSULE;ORAL - EQ 200MG BASE, TABLET;ORAL - 500MG;EQ 85MG BASE, TABLET;ORAL - 60MG;EQ 10MG BASE

drugProductComposition
TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 500MG BASE
TABLET;ORAL - 220MG
TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE
TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE
CAPSULE;ORAL - EQ 200MG BASE
TABLET;ORAL - 500MG;EQ 85MG BASE
TABLET;ORAL - 60MG;EQ 10MG BASE

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13 Gangwal Chemicals
11 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
33 Kerry
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6 Lonza Capsugel
20 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
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4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
2 Qualicaps
38 Roquette
13 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
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3 The Dow Chemical Company
4 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem
1 Vertellus
1 Zhejiang Huakang Pharmaceutical

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44 NEWS #PharmaBuzz

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2 FDF Dossiers

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2 Health Canada Patents

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1 USP
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ANALYTICAL

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Synopsis

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$ 37

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148

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Europe

Canada

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Listed Dossiers

6DRUGS IN DEVELOPMENT

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REF. STANDARDS OR IMPURITIES

EDQM

USP

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US Patents

US Exclusivities

Health Canada Patents

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GLOBAL SALES INFORMATION

US Medicaid (USD)

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Finished Drug Prices

372 RELATED EXCIPIENT COMPANIES

642EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 26159-34-2, Naprelan, Anaprox, Naproxen sodium salt, Miranax, (-)-naproxen sodium

Molecular Formula

C₁₄H₁₃NaO₃

Molecular Weight

252.24 g/mol

InChI Key

CDBRNDSHEYLDJV-FVGYRXGTSA-M

FDA UNII

9TN87S3A3C

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.

1 2D Structure

Naproxen Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(2S)-2-(6-methoxynaphthalen-2-yl)propanoate

2.1.2 InChI

InChI=1S/C14H14O3.Na/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);/q;+1/p-1/t9-;/m0./s1

2.1.3 InChI Key

CDBRNDSHEYLDJV-FVGYRXGTSA-M

2.1.4 Canonical SMILES

CC(C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)[O-].[Na+]

2.1.5 Isomeric SMILES

C[C@@H](C1=CC2=C(C=C1)C=C(C=C2)OC)C(=O)[O-].[Na+]

2.2 Other Identifiers

2.2.1 UNII

9TN87S3A3C

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Aleve

2. Anaprox

3. Methoxypropiocin

4. Naprosin

5. Naprosyn

6. Naproxen

7. Naproxenate, Sodium

8. Proxen

9. Sodium Naproxenate

10. Sodium, Naproxen

11. Synflex

2.3.2 Depositor-Supplied Synonyms

1. 26159-34-2

2. Naprelan

3. Anaprox

4. Naproxen Sodium Salt

5. Miranax

6. (-)-naproxen Sodium

7. Aleve

8. Naproxen (sodium)

9. Naprium

10. Naprux

11. Proxen

12. Sodium (s)-2-(6-methoxynaphthalen-2-yl)propanoate

13. Bayh6689

14. Apo-napro-na

15. (s)-naproxen Sodium Salt

16. Sodium Naproxen

17. Rs-3650

18. Naproxen Sodium Anhydrous

19. Mls000069555

20. 9tn87s3a3c

21. Chebi:7477

22. (-)-sodium (s)-6-methoxy-alpha-methyl-2-naphthaleneacetate

23. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, Sodium Salt, (s)-

24. Bay117031

25. Sodium;(2s)-2-(6-methoxynaphthalen-2-yl)propanoate

26. Bay-117031

27. Ncgc00017097-01

28. Anapran

29. Anaprotab

30. Aprowell

31. Floginex

32. Flogogin

33. Floneks

34. Floxalin

35. Gibinap

36. Gibixen

37. Karoksen

38. Leniartril

39. Monarit

40. Naprodil

41. Naprodol

42. Naprovite

43. Natrioxen

44. Pactens

45. Primeral

46. Smr000058746

47. Sodimax

48. Synflex

49. Flogen

50. Kapnax

51. Opraks

52. Tandax

53. (s)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium Salt

54. Aprol

55. Nixal

56. Cas-26159-34-2

57. Causalon Pro

58. Naproxen Natrium

59. Naprux Gesic

60. Axer Alfa

61. Dsstox_cid_25576

62. Dsstox_rid_80973

63. Dsstox_gsid_45576

64. Sodium (2s)-2-(6-methoxy-2-naphthyl)propanoate

65. A-nox

66. Anaprox Ds

67. Naproxensodium

68. Sunprox

69. Flanax

70. Naproxen Sodium [usan]

71. Einecs 247-486-2

72. Mfcd00058507

73. Unm-0000306098

74. Rs 3650

75. Topcare All Day Pain Relief

76. Unii-9tn87s3a3c

77. Naproxen Sodium [usan:usp]

78. Bay H6689

79. Naproxen (aleve)

80. Sodium (-)-2-(6-methoxy-2-naphthyl)propionate

81. Anaprox (tn)

82. Naproxen Sodium,(s)

83. Naproxen Sodium (usp)

84. L-(-)-6-methoxy-alpha-methyl-2-naphthaleneacetic Acid Sodium Salt

85. Opera_id_1200

86. Lopac-m-1275

87. Schembl7361

88. Mls001076076

89. Mls001424214

90. Naproxen Sodium [vandf]

91. Chembl1200806

92. Dtxsid7045576

93. Naproxen Sodium [mart.]

94. Naproxen Sodium [usp-rs]

95. Naproxen Sodium [who-dd]

96. Naproxen Sodium Salt [mi]

97. Hms1570o04

98. Hms2052g05

99. Hms2230d08

100. Hms3262o06

101. Hms3269j19

102. Hms3413p03

103. Hms3884g04

104. Tox21_110774

105. Tox21_500792

106. Hy-15030a

107. Naproxen Sodium, 98.0-102.0%

108. Naproxen Sodium [ep Impurity]

109. Naproxen Sodium [orange Book]

110. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, Sodium Salt, (s)-

111. Akos015895696

112. Akos015994759

113. Naproxen Sodium [ep Monograph]

114. Naproxen Sodium [usp Impurity]

115. Tox21_110774_1

116. Bcp9000977

117. Ccg-101082

118. Ks-5141

119. Lp00792

120. Naproxen Sodium [usp Monograph]

121. 2-naphthaleneacetic Acid, 6-methoxy-alpha-methyl-, Sodium Salt, L-(-)-

122. Aleve-d Component Naproxen Sodium

123. Ncgc00016166-01

124. Ncgc00016759-04

125. Ncgc00017097-02

126. Ncgc00094127-01

127. Ncgc00261477-01

128. Treximet Component Naproxen Sodium

129. Bcp0726000300

130. Naproxen Sodium Component Of Aleve-d

131. Eu-0100792

132. M3406

133. Naproxen Sodium Component Of Treximet

134. S1626

135. Sw197105-3

136. 59n342

137. Bim-0050769.0001

138. D00970

139. M 1275

140. Sodium (s)-2-(6-methoxy-2-naphthyl)propionate

141. A818221

142. Naproxen Sodium, Meets Usp Testing Specifications

143. Sodium(s)-2-(6-methoxynaphthalen-2-yl)propanoate

144. W-107195

145. Q27107504

146. (2s)-2-(6-methoxy(2-naphthyl))propanoic Acid Sodium Salt

147. (2s)-2-(6-methoxy-2-naphthyl)propanoic Acid Sodium Salt

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

149. Naproxen Sodium, United States Pharmacopeia (usp) Reference Standard

150. 2-naphthaleneacetic Acid, 6-methoxy-.alpha.-methyl-, Sodium Salt, (.alpha.s)- (1:1)

151. Naproxen Sodium, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₁₃NaO₃
Molecular Weight	252.24 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	252.07623855 g/mol
Monoisotopic Mass	252.07623855 g/mol
Topological Polar Surface Area	49.4 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	282
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 12
Drug Name	Aleve
Active Ingredient	Naproxen sodium
Dosage Form	Tablet
Route	Oral
Strength	eq 200mg base
Market Status	Over the Counter
Company	Bayer

2 of 12
Drug Name	Anaprox
Drug Label	Naproxen 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 Ingredient	Naproxen sodium
Dosage Form	Tablet
Route	Oral
Strength	eq 250mg base
Market Status	Prescription
Company	Hoffmann La Roche

3 of 12
Drug Name	Anaprox ds
Drug Label	Naproxen 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 Ingredient	Naproxen sodium
Dosage Form	Tablet
Route	Oral
Strength	eq 500mg base
Market Status	Prescription
Company	Hoffmann La Roche

4 of 12
Drug Name	Naprelan
Drug Label	NAPRELAN* 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 Ingredient	Naproxen sodium
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 750mg base; eq 500mg base; eq 375mg base
Market Status	Prescription
Company	Almatica Pharma

5 of 12
Drug Name	Naprosyn
Drug Label	Naproxen 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 Ingredient	Naproxen
Dosage Form	Tablet; Suspension
Route	Oral
Strength	250mg; 375mg; 500mg; 25mg/ml
Market Status	Prescription
Company	Roche Palo

6 of 12
Drug Name	Naproxen sodium
Drug Label	NAPRELAN* 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 Ingredient	Naproxen sodium
Dosage Form	Tablet, extended release; Tablet; Capsule
Route	Oral
Strength	eq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base
Market Status	Over the Counter; Prescription
Company	Marksans Pharma; Actavis Labs Fl; Teva; Aurobindo Pharma; Banner Pharmacaps; Granules India; Hikma; Amneal Pharms Ny; Glenmark Generics; Perrigo; Contract Pharmacal; Ranbaxy Labs; Dr Reddys Labs

7 of 12
Drug Name	Aleve
Active Ingredient	Naproxen sodium
Dosage Form	Tablet
Route	Oral
Strength	eq 200mg base
Market Status	Over the Counter
Company	Bayer

8 of 12
Drug Name	Anaprox
Drug Label	Naproxen 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 Ingredient	Naproxen sodium
Dosage Form	Tablet
Route	Oral
Strength	eq 250mg base
Market Status	Prescription
Company	Hoffmann La Roche

9 of 12
Drug Name	Anaprox ds
Drug Label	Naproxen 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 Ingredient	Naproxen sodium
Dosage Form	Tablet
Route	Oral
Strength	eq 500mg base
Market Status	Prescription
Company	Hoffmann La Roche

10 of 12
Drug Name	Naprelan
Drug Label	NAPRELAN* 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 Ingredient	Naproxen sodium
Dosage Form	Tablet, extended release
Route	Oral
Strength	eq 750mg base; eq 500mg base; eq 375mg base
Market Status	Prescription
Company	Almatica Pharma

11 of 12
Drug Name	Naprosyn
Drug Label	Naproxen 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 Ingredient	Naproxen
Dosage Form	Tablet; Suspension
Route	Oral
Strength	250mg; 375mg; 500mg; 25mg/ml
Market Status	Prescription
Company	Roche Palo

12 of 12
Drug Name	Naproxen sodium
Drug Label	NAPRELAN* 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 Ingredient	Naproxen sodium
Dosage Form	Tablet, extended release; Tablet; Capsule
Route	Oral
Strength	eq 500mg base; eq 250mg base; eq 200mg base; eq 375mg base
Market Status	Over the Counter; Prescription
Company	Marksans Pharma; Actavis Labs Fl; Teva; Aurobindo Pharma; Banner Pharmacaps; Granules India; Hikma; Amneal Pharms Ny; Glenmark Generics; Perrigo; Contract Pharmacal; Ranbaxy Labs; Dr Reddys Labs

5 Pharmacology and Biochemistry

5.1 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.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cyclooxygenase Inhibitors [MoA]; Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]

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

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DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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Naproxen Sodium

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

22 USDMF

7 CEP/COS

4 EU WC

34 KDMF

11 NDC API

9 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

148 FDF Dossiers

85 FDA Orange Book

11 Europe

18 Canada

4 South Africa

30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 500MG BASE

TABLET;ORAL - 220MG

TABLET, EXTENDED RELEASE;ORAL - EQ 375MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 500MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 750MG BASE

CAPSULE;ORAL - EQ 200MG BASE

TABLET;ORAL - 500MG;EQ 85MG BASE

TABLET;ORAL - 60MG;EQ 10MG BASE

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TABLET;ORAL - EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons