Data / Drug companies / Estradiol/norethindrone acetate
Estradiol/norethindrone acetate: 2 companies and 6 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Estradiol/norethindrone acetate is listed in the FDA National Drug Code Directory by 2 companies, with 6 products in commercial distribution. 0 of the products (0.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated, and the newest product started marketing on May 1, 2019.
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- Companies listing it
- 2
- Products
- 6
- Generic (ANDA) products
- 0 (0.0%)
- Application numbers
- 1
- Routes
- Oral
- Brand names
- Lopreeza, Activella, Lopreeza
- openFDA record search
- api.fda.gov
Companies that list estradiol/norethindrone acetate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals NY LLC | 4 | tablet, film coated | New drug applications (NDA) | January 7, 2019 |
| Amneal Pharmaceuticals LLC | 2 | tablet, film coated | New drug applications (NDA) | May 1, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 6 | 100% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 4 | 66.7% |
| Authorized generics (NDA) | 2 | 33.3% |
Pharmacologic classes
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.