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Data / Drug companies / Norelgestromin and ethinyl estradiol

Norelgestromin and ethinyl estradiol: 8 companies and 8 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Norelgestromin and ethinyl estradiol is listed in the FDA National Drug Code Directory by 8 companies, with 8 products in commercial distribution. 7 of the products (87.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are patch, and the newest product started marketing on October 1, 2026.

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Companies listing it
8
Products
8
Generic (ANDA) products
7 (87.5%)
Application numbers
4
Routes
Transdermal
Brand names
Zafemy, Xulane, Gwyn Lo
openFDA record search
api.fda.gov

Companies that list norelgestromin and ethinyl estradiol

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
A-S Medication Solutions1patchGeneric drugs (ANDA)April 16, 2014
Amneal Pharmaceuticals LLC1patchGeneric drugs (ANDA)June 28, 2020
AvKARE1patchGeneric drugs (ANDA)May 15, 2023
Bryant Ranch Prepack1patchGeneric drugs (ANDA)June 28, 2020
Mylan Pharmaceuticals Inc.1patchGeneric drugs (ANDA)April 16, 2014
Viatris Specialty LLC1patchNew drug applications (NDA)October 1, 2026
Zydus Lifesciences Limited1patchGeneric drugs (ANDA)November 21, 2023
Zydus Pharmaceuticals USA Inc.1patchGeneric drugs (ANDA)November 21, 2023

Dosage forms

Dosage formProductsShare
Patch8100%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)787.5%
New drug applications (NDA)112.5%

Pharmacologic classes

ClassProducts
Estrogen8
Progestin8

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.