Drug
Who makes norelgestromin and ethinyl estradiol?
8 companies list norelgestromin and ethinyl estradiol as a human prescription drug, including under the names Gwyn Lo, XULANE, ZAFEMY. Forms: patch. Routes: transdermal.
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 norelgestromin and ethinyl estradiol
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Viatris Inc.India | patch | NDANDA219990 | 1 | 18 |
| Zydus Lifesciences LimitedIndia | patch | ANDAANDA214594 | 1 | 12 |
| International Medication Systems, Ltd.United States | patch | ANDAANDA200910 | 1 | 3 |
| Amneal Ireland LimitedIreland | patch | ANDAANDA213950 | 1 | 1 |
| Bryant Ranch PrepackUnited States | patch | ANDAANDA213950 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | patch | ANDAANDA214594 | 1 | 1 |
| AvKARE | patch | ANDAANDA213950 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | patch | ANDAANDA200910 | 1 | 0 |
Enquiry
Common questions
- Who makes norelgestromin and ethinyl estradiol?
- 8 companies list norelgestromin and ethinyl estradiol as a human prescription drug in the openFDA NDC Directory, led by Viatris Inc., Zydus Lifesciences Limited, International Medication Systems, Ltd., Amneal Ireland Limited, Bryant Ranch Prepack. 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 Gwyn Lo?
- 7 companies list norelgestromin and ethinyl estradiol under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.