Data / Drug companies / Norethindrone acetate and ethinyl estradiol
Norethindrone acetate and ethinyl estradiol: 10 companies and 25 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Norethindrone acetate and ethinyl estradiol is listed in the FDA National Drug Code Directory by 10 companies, with 25 products in commercial distribution. 25 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; kit; tablet, film coated, and the newest product started marketing on August 13, 2025.
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- Companies listing it
- 10
- Products
- 25
- Generic (ANDA) products
- 25 (100.0%)
- Application numbers
- 16
- Routes
- Oral
- Brand names
- Junel 21 Day, Loestrin 21 Day, Fyavolv, Blisovi Fe 1.5/30, Tri-Legest Fe 28 Day, Jinteli, Luizza 1.5/30, Aurovela 1.5/30
- openFDA record search
- api.fda.gov
Companies that list norethindrone acetate and ethinyl estradiol
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Lupin Pharmaceuticals, Inc. | 6 | kit; tablet, film coated | Generic drugs (ANDA) | August 13, 2025 |
| Glenmark Pharmaceuticals Inc., USA | 4 | tablet | Generic drugs (ANDA) | June 5, 2018 |
| Mylan Pharmaceuticals Inc. | 3 | tablet; kit | Generic drugs (ANDA) | December 16, 2019 |
| Teva Pharmaceuticals USA, Inc. | 3 | tablet; kit | Generic drugs (ANDA) | October 26, 2007 |
| Aurobindo Pharma Limited | 2 | tablet | Generic drugs (ANDA) | June 26, 2017 |
| Teva Women's Health LLC | 2 | tablet | Generic drugs (ANDA) | February 26, 2015 |
| Xiromed, LLC | 2 | tablet | Generic drugs (ANDA) | January 29, 2025 |
| A-S Medication Solutions | 1 | tablet | Generic drugs (ANDA) | January 20, 2016 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | September 18, 2003 |
| Teva Pharmaceuticals USA, Inc. | 1 | tablet | Generic drugs (ANDA) | February 17, 2011 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 17 | 68% |
| Kit | 6 | 24% |
| Tablet, film coated | 2 | 8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 25 | 100% |
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.