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    Chemistry

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    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
    Norethisterone Acetate
    Acetate ester of norethindrone that is used as a long-term contraceptive (CONTRACEPTIVE AGENTS).
    1 2D Structure

    Norethisterone 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 Weight 340.5 g/mol
    Molecular Formula C22H28O3
    XLogP33.5
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass340.20384475 g/mol
    Monoisotopic Mass340.20384475 g/mol
    Topological Polar Surface Area43.4 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity695
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    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 2  
    Drug NameNorethindrone acetate
    PubMed HealthNorethindrone Acetate/Ethinyl Estradiol/Ferrous Fumarate (By mouth)
    Drug LabelAYGESTIN (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 IngredientNorethindrone acetate
    Dosage FormTablet
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyAmneal Pharms; Glenmark Generics; Barr

    2 of 2  
    Drug NameNorethindrone acetate
    PubMed HealthNorethindrone Acetate/Ethinyl Estradiol/Ferrous Fumarate (By mouth)
    Drug LabelAYGESTIN (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 IngredientNorethindrone acetate
    Dosage FormTablet
    RouteOral
    Strength5mg
    Market StatusPrescription
    CompanyAmneal 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]

    API Reference Price

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MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"9.63","actualQuantity":"9.63","unit":"KGS","unitRateFc":"6000","totalValueFC":"63080","currency":"EUR","unitRateINR":"546000","date":"16-May-2024","totalValueINR":"5257980","totalValueInUsd":"63080","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"3516467","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"KLOOSTERSTRAAT 6,5349 AB OSS.SDNFSDNF NETHERLANDS","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719253800,"product":"NORETHINDRONE ACETATE (MICRONIZED) USP (BATCH NO. : L00049439)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"8.45","actualQuantity":"8.445","unit":"KGS","unitRateFc":"6000","totalValueFC":"55356.2","currency":"EUR","unitRateINR":"547200","date":"25-Jun-2024","totalValueINR":"4621104","totalValueInUsd":"55356.2","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"4177959","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"KLOOSTERSTRAAT 6,5349 AB OSS.SDNFSDNF NETHERLANDS","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"NORETHINDRONE ACETATE (MICRONIZED) USP (BATCH NO. : L00049439)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"8.55","actualQuantity":"8.55","unit":"KGS","unitRateFc":"5450","totalValueFC":"51145.7","currency":"EUR","unitRateINR":"500037.5","date":"06-Jul-2024","totalValueINR":"4275320.63","totalValueInUsd":"51145.7","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"4355615","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"KLOOSTERSTRAAT 6,5349 AB OSS.SDNFSDNF NETHERLANDS","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720204200,"product":"NORETHINDRONE ACETATE (MICRONIZED) USP (BATCH NO. : L00049439)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"9.63","actualQuantity":"9.63","unit":"KGS","unitRateFc":"5450","totalValueFC":"57606.2","currency":"EUR","unitRateINR":"500037.5","date":"06-Jul-2024","totalValueINR":"4815361.13","totalValueInUsd":"57606.2","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"4355615","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"KLOOSTERSTRAAT 6,5349 AB OSS.SDNFSDNF NETHERLANDS","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"NORETHINDRONE ACETATE MICRONIZED (BATCH NO. L00049578)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"5450","totalValueFC":"241755.5","currency":"EUR","unitRateINR":"505215","date":"20-Jul-2024","totalValueINR":"20208600","totalValueInUsd":"241755.5","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"4614127","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"KLOOSTERSTRAAT 6 5349AB OSS THE NETHERLANDSSDNF NL","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728930600,"product":"NORETHINDRONE ACETATE MICRONIZED","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"8886.3","totalValueFC":"358934.2","currency":"USD","unitRateINR":"754000","date":"15-Oct-2024","totalValueINR":"30160000","totalValueInUsd":"358934.2","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29372300","bill_no":"6123295","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM","supplierAddress":"MOLENEIND,KLOOSTERSTRAAT 6, 5394 AB OSS,DIOSITE,VEERSEMEER 4, SDNF Netherlands","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"NORETHINDRONE ACETATE MICRONIZED","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"10.9","totalValueFC":"3318.6","currency":"USD","unitRateINR":"929.5","date":"25-Oct-2024","totalValueINR":"278850","totalValueInUsd":"3318.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29372300","bill_no":"6318618","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM","supplierAddress":"KLOOSTERSTRAAT 6 5349 AB OSS SDNF Netherlands","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"NORETHINDRONE ACETATE MICRONIZED (BATCH NO.L00049578) (500 GMS) NORETHINDRONE ACETATE USP (API)","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"ASPEN API","supplierCountry":"NETHERLANDS","foreign_port":"AMSTERDAM, SCHIPHOL","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"5450","totalValueFC":"2932","currency":"EUR","unitRateINR":"494860","date":"29-Nov-2024","totalValueINR":"247430","totalValueInUsd":"2932","indian_port":"Bombay Air","hs_no":"29372300","bill_no":"6949523","productDescription":"API","marketType":"REGULATED MARKET","country":"NETHERLANDS","selfForZScoreResived":"Micronized","supplierPort":"AMSTERDAM, SCHIPHOL","supplierAddress":"KLOOSTERSTRAAT 6 5349 AB OSS THE NE THERLAND Oss, , Netherlands SDNF Netherlands","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
    15-Mar-2021
    29-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL-28 - 0.02MG;1MG

    USFDA APPLICATION NUMBER - 17354

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    DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG

    USFDA APPLICATION NUMBER - 17355

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    DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG

    USFDA APPLICATION NUMBER - 17875

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    DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federa...DOSAGE - TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17876

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    DOSAGE - TABLET;ORAL-21 - 0.02MG,0.03MG,0.035...DOSAGE - 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**

    USFDA APPLICATION NUMBER - 20130

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    DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 203667

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    DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG

    USFDA APPLICATION NUMBER - 203696

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    DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, OR...DOSAGE - INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

    USFDA APPLICATION NUMBER - 203696

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    DOSAGE - CAPSULE;ORAL - 0.02MG;1MG

    USFDA APPLICATION NUMBER - 204426

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    DOSAGE - TABLET, CHEWABLE, TABLET;ORAL - 0.01...DOSAGE - TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A

    USFDA APPLICATION NUMBER - 204654

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    DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR

    USFDA APPLICATION NUMBER - 20870

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    DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR

    USFDA APPLICATION NUMBER - 20870

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    DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal ...DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20907

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    DOSAGE - TABLET;ORAL - 1MG;0.5MG

    USFDA APPLICATION NUMBER - 20907

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    DOSAGE - TABLET;ORAL - 0.0025MG;0.5MG

    USFDA APPLICATION NUMBER - 21065

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    DOSAGE - TABLET;ORAL - 0.005MG;1MG **Federal ...DOSAGE - TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21065

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    DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal R...DOSAGE - TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21871

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    DOSAGE - TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

    USFDA APPLICATION NUMBER - 22501

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    ABOUT THIS PAGE

    Norethisterone Acetate Manufacturers

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

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

    Norethisterone Acetate Suppliers

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

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

    Norethisterone Acetate USDMF

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

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

    click here to find a list of Norethisterone Acetate suppliers with USDMF on PharmaCompass.

    Norethisterone Acetate JDMF

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

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

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

    click here to find a list of Norethisterone Acetate suppliers with JDMF on PharmaCompass.

    Norethisterone Acetate CEP

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

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

    click here to find a list of Norethisterone Acetate suppliers with CEP (COS) on PharmaCompass.

    Norethisterone Acetate WC

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

    click here to find a list of Norethisterone Acetate suppliers with Written Confirmation (WC) on PharmaCompass.

    Norethisterone Acetate NDC

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

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Norethisterone Acetate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

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

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

    Compounded drug products

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

    click here to find a list of Norethisterone Acetate suppliers with NDC on PharmaCompass.

    Norethisterone Acetate GMP

    Norethisterone Acetate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

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

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

    Norethisterone Acetate CoA

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

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

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

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