Data / Drug companies / Norethindrone and ethinyl estradiol
Norethindrone and ethinyl estradiol: 12 companies and 28 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Norethindrone and ethinyl estradiol is listed in the FDA National Drug Code Directory by 12 companies, with 28 products in commercial distribution. 28 of the products (100.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are kit; tablet, and the newest product started marketing on October 10, 2026.
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- Companies listing it
- 12
- Products
- 28
- Generic (ANDA) products
- 28 (100.0%)
- Application numbers
- 20
- Routes
- Oral
- Brand names
- Nortrel 28 Day, Alyacen 1/35, Nortrel 7/7/7 (28 Day Regimen), Necon, Dasetta 1/35, Cyonanz, Kaitlib Fe, Alyacen 7/7/7
- openFDA record search
- api.fda.gov
Companies that list norethindrone and ethinyl estradiol
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 6 | kit; tablet | Generic drugs (ANDA) | October 16, 2006 |
| A-S Medication Solutions | 3 | kit | Generic drugs (ANDA) | October 21, 2016 |
| Aurobindo Pharma Limited | 3 | kit | Generic drugs (ANDA) | October 21, 2016 |
| Glenmark Pharmaceuticals Inc., USA | 3 | kit | Generic drugs (ANDA) | January 19, 2012 |
| Lupin Pharmaceuticals, Inc. | 3 | kit | Generic drugs (ANDA) | February 7, 2021 |
| NorthStar Rx LLC | 3 | kit | Generic drugs (ANDA) | March 27, 2012 |
| Proficient Rx LP | 2 | kit | Generic drugs (ANDA) | January 19, 2012 |
| Amneal Pharmaceuticals NY LLC | 1 | kit | Generic drugs (ANDA) | June 29, 2018 |
| Apotex Corp. | 1 | kit | Generic drugs (ANDA) | October 10, 2026 |
| Dr. Reddy's Laboratories Inc. | 1 | kit | Generic drugs (ANDA) | April 1, 2024 |
| Mayne Pharma Inc. | 1 | kit | Generic drugs (ANDA) | October 12, 2020 |
| Naari Pte Limited | 1 | kit | Generic drugs (ANDA) | December 31, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Kit | 27 | 96.4% |
| Tablet | 1 | 3.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 28 | 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.