Active ingredient
Mifepristone
5 finished FDA listings contain Mifepristone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- MIFEPRISTONE
- Dosage forms
- Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 200 mg/1 · 300 mg/1
- Brand names in FDA listings
- Korlym
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6964
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202107 | CORCEPT THERAP | 2012-02-17 | 2 |
| ANDA 091178 | GENBIOPRO | 2019-04-11 | 1 |
| ANDA 211436 | TEVA PHARMS USA INC | 2020-08-03 | 1 |
| ANDA 216616 | EVITA SOLUTIONS | 2025-09-30 | 1 |
Official labeling on DailyMed
- MIFEPRISTONE TABLET [EVITA SOLUTIONS LLC] · version 6 · 2026-09-08
- MIFEPRISTONE TABLET [GENBIOPRO, INC.] · version 10 · 2026-06-10
- KORLYM (MIFEPRISTONE) TABLET [CORCEPT THERAPEUTICS INCORPORATED] · version 26 · 2025-10-06
- MIFEPRISTONE TABLET [CORCEPT THERAPEUTICS INCORPORATED] · version 3 · 2025-10-06
- MIFEPRISTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] · version 1 · 2024-01-22
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.