Drug
Who makes levonorgestrel and ethinyl estradiol?
19 companies list levonorgestrel and ethinyl estradiol as a human prescription drug, including under the names Balcoltra, Tyblume, ALTAVERA, Afirmelle, Amethyst, Aubra EQ, Aviane, Ayuna. 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 levonorgestrel and ethinyl estradiol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Lupin LimitedIndia | kit | ANDAANDA091408, ANDA091425, ANDA091440 | 6 | 14 |
| Teva Pharmaceutical Industries Ltd.Canada | kit; tablet | ANDAANDA075796, ANDA075803, ANDA075866 | 4 | 6 |
| Glenmark Pharmaceuticals Inc., USAIndia | kit; tablet | ANDAANDA091452, ANDA202791, ANDA203164 | 3 | 9 |
| Aurobindo Pharma LimitedIndia | kit | ANDAANDA206850, ANDA206866, ANDA206886 | 3 | 6 |
| International Medication Systems, Ltd.United States | kit | ANDAANDA090719, ANDA091408, ANDA201088 | 3 | 3 |
| Bryant Ranch PrepackUnited States | kit | ANDAANDA079102, ANDA201088, ANDA206886 | 3 | 1 |
| Mayne Pharma International Pty Ltd.Australia | kit | ANDAANDA073594, ANDA076625, ANDA077681 | 3 | 1 |
| Xiromed LLCIndia | kit | ANDAANDA079064, ANDA079102, ANDA201088 | 3 | 1 |
| Northstar Rx, LLC, | kit | ANDAANDA090716, ANDA090719, ANDA090721 | 3 | 0 |
| Apotex Inc.Canada | kit | ANDAANDA207033, ANDA207065 | 2 | 6 |
| Afaxys Pharma LLCUnited States | kit | ANDAANDA206866, ANDA206886 | 2 | 1 |
| Naari Pte LimitedIndia | kit | ANDAANDA207033, ANDA207065 | 2 | 1 |
| Acella Pharmaceuticals, LLCUnited States | kit | NDANDA208612 | 1 | 1 |
| Avion Pharmaceuticals, LLCUnited States | kit | NDANDA208612 | 1 | 1 |
| Proficient Rx LPUnited States | kit | ANDAANDA075796 | 1 | 1 |
| Dr. Reddys Laboratories Limited | kit | ANDAANDA090721 | 1 | 0 |
| Exeltis USA, Inc. | kit | NDANDA209405 | 1 | 0 |
| Ingenus Pharmaceuticals, LLC | tablet | ANDAANDA091692 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | kit | ANDAANDA200245 | 1 | 0 |
Enquiry
Common questions
- Who makes levonorgestrel and ethinyl estradiol?
- 19 companies list levonorgestrel and ethinyl estradiol as a human prescription drug in the openFDA NDC Directory, led by Lupin Limited, Teva Pharmaceutical Industries Ltd., 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 Balcoltra?
- 16 companies list levonorgestrel and ethinyl estradiol under an abbreviated new drug application (ANDA), the application type used for generics, and 3 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.