Quick answers
- What is Danazol used for?
- The FDA-approved label (Danazol, Chartwell RX, LLC., October 10, 2024) says: “Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Danazol have a boxed warning?
- Yes. The FDA label for Danazol has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Danazol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Danazol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Danazol?
- 4 companies list prescription products of Danazol in the FDA NDC Directory, including Chartwell RX, LLC, Teva Pharmaceuticals USA, Inc. and Lannett Company, Inc..
What Danazol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
— FDA label: Danazol, Chartwell RX, LLC., effective October 10, 2024. Read the full label on DailyMed →
The FDA has 4 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.
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. Read it on the full label →
4 of 4 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 11 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| danazol 100 mg capsule | Generic | $2.18 per capsule |
| danazol 200 mg capsule | Generic | $2.67 per capsule |
| danazol 50 mg capsule | Generic | $1.64 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Chartwell RX, LLC3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Lannett Company, Inc.3 products
- Proficient Rx LP2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA074582Barr · August 9, 1996
- ANDA077246Lannett Co Inc · September 28, 2005
- ANDA078214Lannett · April 19, 2007
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) | 197554, 197555, 197556 |
|---|---|
| SPL set ID of the quoted label | 55ad6325-16f6-4f0c-a1dc-734847052d0b |
| FDA labels (SPL) | 4 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | DANAZOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Danazol, Chartwell RX, LLC., effective October 10, 2024; 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 →