Drug
Who makes norethindrone and ethinyl estradiol?
11 companies list norethindrone and ethinyl estradiol as a human prescription drug, including under the names ALYACEN 1/35, ALYACEN 7/7/7, Aranelle, BRIELLYN, Balziva, Cyonanz, Dasetta 1/35, Dasetta 7/7/7. Forms: kit; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing norethindrone and ethinyl estradiol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Teva Pharmaceutical Industries Ltd.Canada | kit; tablet | ANDAANDA072693, ANDA072695, ANDA072696 | 6 | 6 |
| Lupin LimitedIndia | kit | ANDAANDA091332, ANDA201886, ANDA203448 | 3 | 14 |
| Glenmark Pharmaceuticals Inc., USAIndia | kit | ANDAANDA090538, ANDA091634, ANDA091636 | 3 | 9 |
| Aurobindo Pharma LimitedIndia | kit | ANDAANDA207054, ANDA207055, ANDA207056 | 3 | 6 |
| International Medication Systems, Ltd.United States | kit | ANDAANDA072695, ANDA091634, ANDA207054 | 3 | 3 |
| Northstar Rx, LLC, | kit | ANDAANDA090946, ANDA090948, ANDA091204 | 3 | 0 |
| Proficient Rx LPUnited States | kit | ANDAANDA075478, ANDA091634 | 2 | 1 |
| Dr. Reddy's Laboratories LimitedIndia | kit | ANDAANDA091204 | 1 | 15 |
| Mayne Pharma International Pty Ltd.Australia | kit | ANDAANDA091204 | 1 | 1 |
| Naari Pte LimitedIndia | kit | ANDAANDA206864 | 1 | 1 |
| Amneal Pharmaceuticals NY LLC | kit | ANDAANDA078892 | 1 | 0 |
Enquiry
Common questions
- Who makes norethindrone and ethinyl estradiol?
- 11 companies list norethindrone and ethinyl estradiol as a human prescription drug in the openFDA NDC Directory, led by Teva Pharmaceutical Industries Ltd., Lupin Limited, Glenmark Pharmaceuticals Inc., USA, Aurobindo Pharma Limited, International Medication Systems, Ltd.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic norethindrone and ethinyl estradiol?
- 11 companies list norethindrone and ethinyl estradiol under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.