Drug

Who makes norethindrone acetate and ethinyl estradiol?

10 companies list norethindrone acetate and ethinyl estradiol as a human prescription drug, including under the names Aurovela 1.5/30, Aurovela 1/20, BLISOVI FE 1.5/30, Blisovi 24 Fe, Blisovi Fe 1/20, Fyavolv, Hailey 1.5/30, Jinteli. Forms: kit; tablet; tablet, film coated. 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 acetate and ethinyl estradiol

CompanyFormsApplicationNDCsRegistered sites
Lupin LimitedIndiakit; tablet, film coatedANDAANDA091398, ANDA201584, ANDA201585614
Glenmark Pharmaceuticals Inc., USAIndiatabletANDAANDA203038, ANDA206969, ANDA20929749
Teva Pharmaceutical Industries Ltd.Canadakit; tabletANDAANDA076105, ANDA076221, ANDA07638046
Mylan Pharmaceuticals, Inc.kit; tabletANDAANDA202741, ANDA202770, ANDA20277130
Aurobindo Pharma LimitedIndiatabletANDAANDA207506, ANDA20758126
Nivagen Pharmaceuticals LLCUnited StatestabletANDAANDA20343522
Teva Women's Health LLCUnited StatestabletANDAANDA076380, ANDA07638121
Xiromed LLCIndiatabletANDAANDA202770, ANDA20277121
International Medication Systems, Ltd.United StatestabletANDAANDA20696913
Proficient Rx LPUnited StatestabletANDAANDA07638011
Enquiry

Common questions

Who makes norethindrone acetate and ethinyl estradiol?
10 companies list norethindrone acetate and ethinyl estradiol as a human prescription drug in the openFDA NDC Directory, led by Lupin Limited, Glenmark Pharmaceuticals Inc., USA, Teva Pharmaceutical Industries Ltd., Mylan Pharmaceuticals, Inc., Aurobindo Pharma Limited. 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 acetate and ethinyl estradiol?
10 companies list norethindrone acetate 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.