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Norethindrone Acetate

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

22 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 6 NDC API, 12 Listed Suppliers

DEVELOPMENTS

24 Drug(s) in Development

24 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

DOSSIERs // Finished Dosage Formulations

135 Dossiers, 118 FDA Orange Book, 9 Europe, 6 Canada, 2 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

TABLET;ORAL-28 - 0.02MG;1MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG
CAPSULE;ORAL - 0.02MG;1MG
TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG;0.5MG
TABLET;ORAL - 0.0025MG;0.5MG
TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

Suppliers, 38 Kerry, 23 Roquette, 19 BASF, 15 Microlex e.U, 13 Seppic, 12 Sigachi Industries, 11 Corel Pharma Chem, 11 Gangwal Chemicals, 9 Gangwal Healthcare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 7 Ideal Cures Pvt Ltd, 7 DFE Pharma, 6 Lonza Capsugel, 6 Nanjing Well Pharmaceutical, 5 Vasa Pharmachem, 5 SPI Pharma, 4 Ingredion Pharma Solutions, 4 Actylis, 4 Boai NKY Pharmaceuticals Ltd, 4 Prachin Chemical, 3 Kima Chemical, 3 Pharmatrans-Sanaq, 2 Clariant, 2 Ulanqab Kema New Material, 2 Jai Radhe Sales, 2 Rochem International Inc, 2 The Dow Chemical Company, 2 DKSH, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Alcedo Pharmachem, 1 Huzhou Sunflower Pharmaceutical Co. Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 ACG Worldwide, 1 Pfanstiehl, 1 Nanjing Bold Chemical, 1 Qualicaps, 1 Doshion Polyscience, 1 Aeon Procare

EXCIPIENTS BY APPLICATIONS

77 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 36 Direct Compression, 34 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 26 Granulation, 25 Solubilizers, 20 Thickeners and Stabilizers, 20 Lubricants & Glidants, 18 Taste Masking, 15 Film Formers & Plasticizers, 14 Co-Processed Excipients, 13 Parenteral, 9 Emulsifying Agents, 8 Topical, 8 API Stability Enhancers, 7 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 2 Coloring Agents

GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 10 Finished Drug Prices

MARKET PLACE

7 APIs

7 APIs

PATENTS

8 US Patents, 4 US Exclusivities

ANALYTICAL SOLUTION(s)

2 EDQM Standards, 1 USP Standards, 3 Other Ref. Standards

DIGITAL CONTENT

2 Data Compilations & Company Tracker #PharmaFlow, 47 News

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US DMFs Filed

CEP/COS Certifications

JDMFs Filed

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API REF. PRICE (USD / KG)

7,470

API Market Place

INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

118

Europe

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

24.00

Annual Reports

528.00

FDF Market Place

EXCIPIENTS

248

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

Other Listed Suppliers

SERVICES

Also known as: Norethisterone acetate, 19-norethindrone acetate, 51-98-9, Aygestin, Norlutin acetate, Orlutate

Molecular Formula

C₂₂H₂₈O₃

Molecular Weight

340.5 g/mol

InChI Key

IMONTRJLAWHYGT-ZCPXKWAGSA-N

FDA UNII

9S44LIC7OJ

Acetate ester of norethindrone that is used as a long-term contraceptive (CONTRACEPTIVE AGENTS).

1 2D Structure

Norethindrone Acetate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[(8R,9S,10R,13S,14S,17R)-17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate

2.1.2 InChI

InChI=1S/C22H28O3/c1-4-22(25-14(2)23)12-10-20-19-7-5-15-13-16(24)6-8-17(15)18(19)9-11-21(20,22)3/h1,13,17-20H,5-12H2,2-3H3/t17-,18+,19+,20-,21-,22-/m0/s1

2.1.3 InChI Key

IMONTRJLAWHYGT-ZCPXKWAGSA-N

2.1.4 Canonical SMILES

CC(=O)OC1(CCC2C1(CCC3C2CCC4=CC(=O)CCC34)C)C#C

2.1.5 Isomeric SMILES

CC(=O)O[C@]1(CC[C@@H]2[C@@]1(CC[C@H]3[C@H]2CCC4=CC(=O)CC[C@H]34)C)C#C

2.2 Other Identifiers

2.2.1 UNII

9S44LIC7OJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Aygestin

2. Estr-4-en-3-one, 17-(acetyloxy)-17-ethynyl-, (17beta)-

3. Norethindrone Acetate, (17alpha)-(+-)-isomer

4. Norethindrone Acetate, (17alpha)-isomer

5. Norethisterone Acetate

6. Norlutate

2.3.2 Depositor-Supplied Synonyms

1. Norethisterone Acetate

2. 19-norethindrone Acetate

3. 51-98-9

4. Aygestin

5. Norlutin Acetate

6. Orlutate

7. Norethisteron Acetate

8. Norlutate

9. Enta

10. 19-norethisterone Acetate

11. Primolut-nor

12. Norethindrone 17-acetate

13. Norethysterone Acetate

14. 19-norethynyltestosterone Acetate

15. Norethynyltestosterone Acetate

16. (17-alpha)-norethindrone Acetate

17. 17alpha-ethynyl-19-nortestosterone Acetate

18. Norethindrone Acetate [usp]

19. Sh 420

20. Milligynon

21. Miniphase

22. Progylut

23. Norethynyltestosterone

24. Milli-anovlar

25. Norlutin A

26. Norlutine Acetate

27. 17-alpha-ethinyl-19-nortestosterone Acetate

28. 17-alpha-ethynyl-19-nortestosterone Acetate

29. 17-hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one Acetate

30. Nsc-22844

31. Norethisterone 17-acetate

32. 17alpha-ethinyl-19-nortestosterone 17beta-acetate

33. 17alpha-ethinyl-19-nortestosterone-17beta-acetate

34. 17alpha-ethynyl-17-hydroxyestr-4-en-3-one Acetate

35. 9s44lic7oj

36. 17-alpha-ethinyl-19-nortestosterone-17-beta-acetate

37. 17-alpha-ethynyl-17-hydroxyestr-4-en-3-one Acetate

38. 17-acetoxy-19-nor-17alpha-pregn-4-en-20-yn-3-one

39. 17-acetoxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one

40. 17alpha-ethynyl-17beta-acetoxy-19-norandrost-4-en-3-one

41. 17beta-acetoxy-19-nor-17alpha-pregn-4-en-20-yn-3-one

42. Chebi:7628

43. [(8r,9s,10r,13s,14s,17r)-17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] Acetate

44. 17-hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one Acetate

45. 17beta-hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one Acetate

46. 17-acetyloxy(17-alpha)-19-norpregn-4-estren-17-beta-ol-acetate-3-one

47. Sh-420

48. Gestakadin

49. Monogest

50. 19-nor-17alpha-ethynyltestosterone Acetate

51. Nsc 22844

52. 17.alpha.-ethynyl-19-nortestosterone Acetate

53. Norethindrone Acetate (usp)

54. Norethisterone Acetate (jan)

55. Norlutin-a

56. 17-hydroxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one Acetate

57. Norethisterone Acetate [jan]

58. (17beta)-17-ethynyl-3-oxoestr-4-en-17-yl Acetate

59. Ccris 485

60. Ethinyl-nortestosterone Acetate

61. Einecs 200-132-0

62. Unii-9s44lic7oj

63. Brn 2064104

64. Sh-420c

65. 19-norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17.alpha.)-

66. Ncgc00183366-01

67. Aygestin (tn)

68. Norethindrone-acetate

69. Norethisteroni Acetas

70. 17.alpha.-ethinyl-19-nortestosterone Acetate

71. 19-nor-17alpha-pregn-4-en-20-yn-3-one, 17-acetoxy-

72. Estr-4-en-3-one, 17alpha-ethynyl-17-hydroxy-, Acetate

73. (17-alpha)-17-(acetyloxy)-19-norpregn-4-en-20-yn-3-one

74. 17-alpha-ethynyl-17-beta-acetoxy-19-norandrost-4-en-3-one

75. Dsstox_cid_1071

76. Norethisterone Acetate (norethindrone Acetate)

77. 17-acetoxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one

78. 17.alpha.-ethinyl-19-nortestosterone 17.beta.-acetate

79. 19-nor-17.alpha.-pregn-4-en-20-yn-3-one, 17-acetoxy-

80. Dsstox_rid_77006

81. Dsstox_gsid_23381

82. Schembl37530

83. 17.beta.-acetoxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one

84. 17-acetyloxy(17.alpha.)-19-norpregn-4-estren-17.beta.-ol-acetate-3-one

85. 17.beta.-hydroxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one Acetate

86. Chembl1201146

87. Dtxsid4023381

88. 19-nor-17-alpha-pregn-4-en-20-yn-3-one, 17-acetoxy-

89. Hms3259a16

90. Norethindrone Acetate [mi]

91. 19-nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-, Acetate

92. 19-norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)

93. Bcp11908

94. Hy-b1710

95. Nsc22844

96. Zinc1849528

97. Tox21_113371

98. Mfcd00271615

99. Norethindrone Acetate [vandf]

100. S5785

101. Akos016010517

102. Norethindrone Acetate [usp-rs]

103. Norethisterone Acetate [mart.]

104. Cs-7730

105. Nc00575

106. Norethisterone Acetate [who-dd]

107. Norethisterone Acetate [who-ip]

108. Cas-51-98-9

109. Ncgc00159500-02

110. Ncgc00183366-07

111. (1s,11s,15s,2r,10r,14r)-14-ethynyl-15-methyl-5-oxotetracyclo[8.7.0.0<2,7>.0<11 ,15>]heptadec-6-en-14-yl Acetate

112. As-13383

113. Cpd001906776

114. Norethindrone Acetate [orange Book]

115. 17a-ethynyl-19-nortestosterone 17b-acetate

116. Femhrt Component Norethindrone Acetate

117. N0450

118. Norethindrone Acetate [usp Monograph]

119. Norethisterone Acetate [ep Monograph]

120. Norethisteroni Acetas [who-ip Latin]

121. En300-49856

122. Oriahnn Component Norethindrone Acetate

123. Activella Component Norethindrone Acetate

124. C08152

125. D00953

126. Myfembree Component Norethindrone Acetate

127. T72561

128. Combipatch Component Norethindrone Acetate

129. Norethindrone Acetate Component Of Femhrt

130. Norethindrone Acetate Component Of Oriahnn

131. Estrostep Fe Component Norethindrone Acetate

132. Norethindrone Acetate Component Of Activella

133. Norethindrone Acetate Component Of Myfembree

134. Norethindrone Acetate Component Of Combipatch

135. Tri-legest Fe Component Norethindrone Acetate

136. 17.alpha.-ethynyl-17-hydroxyestr-4-en-3-one Acetate

137. 19-nor-17.alpha.-pregn-4-en-20-yn-3-one, Acetate

138. Brd-k96037667-001-01-4

139. Lo Loestrin Fe Component Norethindrone Acetate

140. Norethindrone Acetate Component Of Estrostep Fe

141. Q47495694

142. 17.alpha.-ethinyl-19-nortestosterone-17.beta.-acetate

143. Norethindrone Acetate Component Of Lo Loestrin Fe

144. Norethindrone Acetate Component Of Tri-legest Fe

145. Wln: L E5 B666 Ov Mutj E Fov1 F1uu1 -b&ef

146. (17alpha)-3-oxo-19-norpregn-4-en-20-yn-17-yl Acetate

147. 17.alpha.-ethynyl-17.beta.-acetoxy-19-norandrost-4-en-3-one

148. 19-norethindrone Acetate, Vetranal(tm), Analytical Standard

149. Norethindrone Acetate, United States Pharmacopeia (usp) Reference Standard

150. Norethisterone Acetate, European Pharmacopoeia (ep) Reference Standard

151. Norethisterone Acetate For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-03-26

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₈O₃
Molecular Weight	340.5 g/mol
XLogP3	3.5
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	340.20384475 g/mol
Monoisotopic Mass	340.20384475 g/mol
Topological Polar Surface Area	43.4 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	695
Isotope Atom Count	0
Defined Atom Stereocenter Count	6
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Norethindrone acetate
PubMed Health	Norethindrone Acetate/Ethinyl Estradiol/Ferrous Fumarate (By mouth)
Drug Label	AYGESTIN (norethindrone acetate tablets, USP) - 5 mg oral tablets.AYGESTIN (norethindrone acetate tablets, USP), (17-hydroxy-19-nor-17-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindr...
Active Ingredient	Norethindrone acetate
Dosage Form	Tablet
Route	Oral
Strength	5mg
Market Status	Prescription
Company	Amneal Pharms; Glenmark Generics; Barr

2 of 2
Drug Name	Norethindrone acetate
PubMed Health	Norethindrone Acetate/Ethinyl Estradiol/Ferrous Fumarate (By mouth)
Drug Label	AYGESTIN (norethindrone acetate tablets, USP) - 5 mg oral tablets.AYGESTIN (norethindrone acetate tablets, USP), (17-hydroxy-19-nor-17-pregn-4-en-20-yn-3-one acetate), a synthetic, orally active progestin, is the acetic acid ester of norethindr...
Active Ingredient	Norethindrone acetate
Dosage Form	Tablet
Route	Oral
Strength	5mg
Market Status	Prescription
Company	Amneal Pharms; Glenmark Generics; Barr

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Contraceptive Agents, Hormonal

Contraceptive agents that act on the ENDOCRINE SYSTEM. (See all compounds classified as Contraceptive Agents, Hormonal.)

Contraceptive Agents, Female

Chemical substances or agents with contraceptive activity in females. Use for female contraceptive agents in general or for which there is no specific heading. (See all compounds classified as Contraceptive Agents, Female.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Progestin [EPC]; Progesterone Congeners [CS]