Danazol 200 mg capsule is a generic prescription medicine for oral use, made by 4 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20° to 25° C (68° to 77° F).
Key facts
- Active ingredient (INN)
- Danazol
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules, 100 capsules, 30 capsules and 8 more
- Manufacturers
- Proficient RxLannettTeva PharmaceuticalsChartwell RX
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25° C (68° to 77° F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G03XA01 Danazol
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 9 August 1996
- Identifiers
- RxCUI 197554, 197555, 197556DailyMed set ID e19acee5-ff33-45a5-bbbf-801756bc59b4, f2c9b713-aafc-49ca-866e-334d9b5c2e2d, 9e103cf9-f075-48ba-8913-2e44f9442781 +1NDC 0555-0635, 0527-1369, 71205-862 +1Application ANDA074582, ANDA077246
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 capsule in 1 bottle | 62135-477-60 | Chartwell RX | 27 February 2023 |
| 100 capsule in 1 bottle | 0527-1369-01 | Lannett | 28 September 2005 |
| 60 capsule in 1 bottle | 0527-1369-06 | Lannett | 28 September 2005 |
| 100 capsule in 1 bottle | 0555-0635-02 | Teva Pharmaceuticals | 9 August 1996 |
| 60 capsule in 1 bottle | 0555-0635-09 | Teva Pharmaceuticals | 9 August 1996 |
| 100 capsule in 1 bottle | 71205-862-00 | Proficient Rx | 1 April 2022 |
| 30 capsule in 1 bottle | 71205-862-30 | Proficient Rx | 1 April 2022 |
| 500 capsule in 1 bottle | 71205-862-55 | Proficient Rx | 1 April 2022 |
| 60 capsule in 1 bottle | 71205-862-60 | Proficient Rx | 1 April 2022 |
| 120 capsule in 1 bottle | 71205-862-72 | Proficient Rx | 1 April 2022 |
| 90 capsule in 1 bottle | 71205-862-90 | Proficient Rx | 1 April 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 21 June 1976 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Danazol
Clinical summary
Danazol is an androgen indicated for the treatment of endometriosis amenable to hormonal management. It is available as capsules for oral use. MedsAcross supplies Danazol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DanazolFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Danazol prescribing information (Chartwell RX) · U.S. National Library of Medicine, DailyMed
Need Danazol 200 mg capsule for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.