FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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Norethisterone Acetate

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

28 API Suppliers, 12 USDMF, 4 CEP/COS, 1 JDMF, 4 EU WC, 5 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers, 120 FDA Orange Book, 103 Europe, 7 Canada, 9 Australia, 7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A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

1 Rochem International Inc, 5 SPI Pharma, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 35 Direct Compression, 32 Granulation, 31 Disintegrants & Superdisintegrants, 25 Solubilizers, 23 Controlled & Modified Release, 21 Thickeners and Stabilizers, 20 Lubricants & Glidants, 16 Taste Masking, 15 Parenteral, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 9 Emulsifying Agents, 9 Topical, 8 Chewable & Orodispersible Aids, 8 API Stability Enhancers, 6 Rheology Modifiers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 47 News #PharmaBuzz

GLOBAL SALES INFORMATION

13 US Medicaid Prescriptions, 3 Regulatory FDF Prices, 7 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

10 US Patents, 4 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Name of the Firm	Written Confirmation No.	Product Name	Issue Date	Valid Till	Address of the Firm
06/02/2026	Aresko Life Sciences	India	M/s Aresko Life Sciences Private Limited	WC-0297	Norethisterone Acetate BP/USP/EP	2025-07-09	2028-07-08	Village -Sakhanpur, P.O. Pirumadara-244715,Tehsil Ramnagar, Distt. Nainital, Uttarakhand, India
04/06/2025	Ipca Laboratories	India	M/sIPCA Laboratories Limited	WC-0402A2	Norethisterone Acetate Ph. Eur/BP	2020-07-06	2023-05-24	Plot No. 23-24, GIDC Estate, Nandesari-391 340, Dist. Vadodara, Gujarat, India

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Norethisterone Acetate

Norethisterone Acetate

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

28 API Suppliers

12 USDMF

4 CEP/COS

1 JDMF

4 EU WC

5 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

FINISHED DOSAGE FORMULATIONS

246 FDF Dossiers

120 FDA Orange Book

103 Europe

7 Canada

9 Australia

7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

1 Rochem International Inc

5 SPI Pharma

6 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

4 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

19 BASF

2 Clariant

11 Corel Pharma Chem

7 DFE Pharma

1 Doshion Polyscience

11 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures

4 Ingredion Pharma Solutions

26 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

4 Novo Excipients

3 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

23 Roquette

13 Seppic

TABLET;ORAL-28 - 0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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 Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

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