Quick answers
- What is Mifepristone used for?
- The FDA-approved label (Korlym, Corcept Therapeutics Incorporated, September 25, 2025) says: “KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Mifepristone have a boxed warning?
- Yes. The FDA label for Korlym has a boxed warning (“WARNING: TERMINATION OF PREGNANCY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Mifepristone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Mifepristone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Mifepristone?
- 4 companies list prescription products of Mifepristone in the FDA NDC Directory, including Corcept Therapeutics Incorporated, Evita Solutions LLC and Actavis Pharma, Inc..
What Mifepristone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE …
— FDA label: Korlym, Corcept Therapeutics Incorporated, effective September 25, 2025. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: TERMINATION OF PREGNANCY
. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
| Brand names | Korlym |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Corcept Therapeutics Incorporated2 products
- Evita Solutions LLC1 product
- Actavis Pharma, Inc.1 product
- GenBioPro, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202107 KORLYM | Corcept Therap | February 17, 2012 | 7, latest November 5, 2019 2019: Labeling · 2017: Labeling · 2016: Labeling |
Generic approvals (3)
- ANDA091178Genbiopro · April 11, 2019
- ANDA211436Teva Pharms USA Inc · August 3, 2020
- ANDA216616Evita Solutions · September 30, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 311704, 1245262, 1245268 |
|---|---|
| SPL set ID of the quoted label | 542f3fae-8bc8-4f00-9228-e4b66c9ad6a9 |
| FDA labels (SPL) | 5 |
| FDA applications | NDA202107, 3 ANDA |
| Active ingredients (FDA) | MIFEPRISTONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Korlym, Corcept Therapeutics Incorporated, effective September 25, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →