Estrogen, Progestin
Where is Estradiol and Norethindrone made?
8 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 7 factories in the United States, India, Denmark and China.
United States 3India 2Denmark 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals Activella, Lopreeza0.1 mg / 0.5 mg, 1 mg / 0.5 mg · NDC 69238-1252, 60846-231, 69238-1609 +3 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Novo Nordisk A/S - G8, X9 M.Fl.Makes it | Malov, Denmark | Problems found, fixed voluntarilyApr 2026 | |
| Aurobindo Pharma Limited0.1 mg / 0.5 mg, 1 mg / 0.5 mg · NDC 59651-425, 59651-424 | Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 |
| Breckenridge Pharmaceutical, Inc.0.1 mg / 0.5 mg, 1 mg / 0.5 mg · NDC 51991-623, 51991-474 | Pharmaceutics International, Inc.Makes it | Hunt Valley, MD, United States | Problems found, fixed voluntarilyDec 2024 |
| Ingenus Pharmaceuticals, LLC0.1 mg / 0.5 mg, 1 mg / 0.5 mg · NDC 50742-658, 50742-657 | Novast Laboratories Ltd.Makes it, tests it and packages it | Nantong, China | Problems found, fixed voluntarilyJul 2023 |
| Naari Pte. Limited1 mg / 0.5 mg · NDC 79929-012 | Naari Pharma Private LimitedMakes it, tests it and packages it | Rudrapur, India | Not inspected on record |
| Noven Therapeutics, LLC CombiPatch (estradiol/norethindrone acetate transdermal system)0.05 mg per 1 d / 0.14 mg per 1 d, 0.05 mg per 1 d / 0.25 mg per 1 d · NDC 68968-0514, 68968-0525 | Noven Pharmaceuticals, Inc.Makes it and tests it | Miami, FL, United States | Problems found, fixed voluntarilyAug 2026 |
| Teva Pharmaceuticals USA, Inc.1 mg / 0.5 mg · NDC 0093-5455 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xiromed, LLC.0.1 mg / 0.5 mg, 1 mg / 0.5 mg · NDC 70700-303, 70700-330 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Estradiol and 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:
50090-8004,50090-8003 - Physicians Total Care, Inc.:
54868-4677
Recalls
- Jan 7, 2022 · Class III · Teva Pharmaceuticals USA · 2 recall notices
Mislabeling - Jul 30, 2021 · Class II · Noven Pharmaceuticals Inc · 2 recall notices
Failed Stability Specifications; out of specification for shear.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.