Progestin
Where is Norethindrone made?
15 companies sell it under their own name and 9 repackagers rebottle it. Their labels name 9 factories in India, the Netherlands, the United States, China and Germany.
India 4Netherlands 2United States 1China 1Germany 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Afaxys Pharma LLC0.35 mg · NDC 50102-100, 50102-300 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Mylan Laboratories LimitedMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record | |
| Apotex Corp.0.35 mg · NDC 60505-4900 | Aspen Oss B.V.Makes the active ingredient | Oss, Netherlands | Problems found, fixed voluntarilyNov 2022 |
| Naari Pharma Private LimitedMakes it | Rudrapur, India | Not inspected on record | |
| Ohm Laboratories Inc.0.35 mg · NDC 51660-127 | Haupt Pharma Muenster GmbHMakes it | Muenster, Germany | Problems found, fixed voluntarilyNov 2024 |
| N.V. OrganonMakes the active ingredient | Oss, Netherlands | No problems foundSep 2022 | |
| Amneal Pharmaceuticals5 mg · NDC 65162-475 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Aurobindo Pharma Limited0.35 mg · NDC 65862-925, 59651-136 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Glenmark Pharmaceuticals Inc., USA0.35 mg, 5 mg · NDC 68462-303, 68462-305, 68462-304 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Ingenus Pharmaceuticals, LLC5 mg · NDC 50742-267 | Novast Laboratories Ltd.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Lupin Pharmaceuticals, Inc.0.35 mg · NDC 68180-876, 68180-877 | Lupin LimitedMakes it and packages it | Dhar, India | Problems found, fixed voluntarilySep 2024 |
| Naari Pte. Limited0.35 mg · NDC 79929-015 | Naari Pharma Private LimitedMakes it, tests it, packages it and labels it | Rudrapur, India | Not inspected on record |
| Northstar Rx LLC.0.35 mg · NDC 16714-441, 16714-440 | Novast Laboratories Ltd.Makes it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Dr. Reddy's Laboratories Inc.0.35 mg · NDC 75907-075, 75907-074 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.0.35 mg · NDC 0378-7292 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.5 mg · NDC 0555-0211 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.0.35 mg · NDC 0480-3475 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xiromed, LLC.0.35 mg, 5 mg · NDC 70700-317, 70700-316, 70700-326 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Norethindrone in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-6161 - American Health Packaging:
60687-921 - AvKARE, Inc.:
42291-650 - Central Texas Community Health Centers:
76413-118 - Golden State Medical Supply, Inc.:
51407-599 - PD-Rx Pharmaceuticals, Inc.:
72789-439 - Physicians Total Care, Inc.:
54868-4814,54868-4369 - Proficient Rx LP:
63187-748,71205-526,82804-175 - RPK Pharmaceuticals, Inc.:
53002-1793
Recalls
- Mar 18, 2013 · Class III · Physicians Total Care, Inc.
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.