Medicine
Ketoconazole 200 mg tablet
Ketoconazole 200 mg tablet is a generic prescription medicine for oral use, made by 10 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). Protect from moisture.
Key facts
- Active ingredient (INN)
- Ketoconazole
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 10 blister pack and 30 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaStrides PharmaIndiaBryant Ranch PrepackAmerisynBurel PharmaceuticalsDirect_RxA-S Medication SolutionsAmici PharmaGolden State Medical SupplyPD-Rx Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D01AC08 Ketoconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 June 1999
- Identifiers
- RxCUI 197853DailyMed set ID a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7, bc189ce2-3f10-260d-e053-2a95a90ae808, 6d4be760-c723-4f54-a854-12c61cf91703 +9NDC 60429-020, 72189-180, 64380-827 +9Application ANDA075319, ANDA075912, ANDA210457
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 64380-827-06 | Strides PharmaIndia | 26 June 2018 |
| 500 tablet in 1 bottle | 64380-827-07 | Strides PharmaIndia | 26 June 2018 |
| 10 blister pack in 1 box / 10 tablet in 1 blister pack | 51672-4026-0 | Sun Pharmaceutical IndustriesIndia | 15 June 1999 |
| 100 tablet in 1 bottle | 51672-4026-1 | Sun Pharmaceutical IndustriesIndia | 15 June 1999 |
| 500 tablet in 1 bottle | 51672-4026-2 | Sun Pharmaceutical IndustriesIndia | 15 June 1999 |
| 3 blister pack in 1 box / 10 tablet in 1 blister pack | 51672-4026-8 | Sun Pharmaceutical IndustriesIndia | 15 June 1999 |
| 5 blister pack in 1 box / 10 tablet in 1 blister pack | 51672-4026-9 | Sun Pharmaceutical IndustriesIndia | 15 June 1999 |
| 100 tablet in 1 bottle | 87564-051-10 | Amerisyn | 6 August 2026 |
| 30 tablet in 1 bottle | 87564-051-30 | Amerisyn | 6 August 2026 |
| 100 tablet in 1 bottle | 69292-224-01 | Amici Pharma | 21 June 2025 |
| 100 tablet in 1 bottle | 35573-433-02 | Burel Pharmaceuticals | 10 April 2020 |
| 30 tablet in 1 bottle | 35573-433-30 | Burel Pharmaceuticals | 10 April 2020 |
| 10 tablet in 1 bottle | 71335-0439-1 | Bryant Ranch Prepack | 28 April 2010 |
| 30 tablet in 1 bottle | 71335-0439-2 | Bryant Ranch Prepack | 28 April 2010 |
| 40 tablet in 1 bottle | 71335-0439-3 | Bryant Ranch Prepack | 28 April 2010 |
| 60 tablet in 1 bottle | 71335-0439-4 | Bryant Ranch Prepack | 28 April 2010 |
| 8 tablet in 1 bottle | 71335-0439-5 | Bryant Ranch Prepack | 28 April 2010 |
| 7 tablet in 1 bottle | 71335-0439-6 | Bryant Ranch Prepack | 28 April 2010 |
| 14 tablet in 1 bottle | 71335-0439-7 | Bryant Ranch Prepack | 28 April 2010 |
| 90 tablet in 1 bottle | 71335-0439-8 | Bryant Ranch Prepack | 28 April 2010 |
| 10 tablet in 1 bottle | 71335-1849-1 | Bryant Ranch Prepack | 21 December 2021 |
| 30 tablet in 1 bottle | 71335-1849-2 | Bryant Ranch Prepack | 21 December 2021 |
| 40 tablet in 1 bottle | 71335-1849-3 | Bryant Ranch Prepack | 21 December 2021 |
| 60 tablet in 1 bottle | 71335-1849-4 | Bryant Ranch Prepack | 21 December 2021 |
| 8 tablet in 1 bottle | 71335-1849-5 | Bryant Ranch Prepack | 21 December 2021 |
| 7 tablet in 1 bottle | 71335-1849-6 | Bryant Ranch Prepack | 21 December 2021 |
| 14 tablet in 1 bottle | 71335-1849-7 | Bryant Ranch Prepack | 21 December 2021 |
| 90 tablet in 1 bottle | 71335-1849-8 | Bryant Ranch Prepack | 21 December 2021 |
| 7 tablet in 1 bottle | 72189-180-07 | Direct Rx | 24 February 2021 |
| 7 tablet in 1 bottle | 72189-428-07 | Direct_Rx | 1 March 2023 |
| 7 tablet in 1 bottle | 50090-6142-1 | A-S Medication Solutions | 3 October 2022 |
| 100 tablet in 1 bottle | 60429-020-01 | Golden State Medical Supply | 15 December 2014 |
| 30 tablet in 1 bottle, plastic | 72789-052-30 | PD-Rx Pharmaceuticals | 8 December 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.
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 Ketoconazole
Clinical summary
Ketoconazole is an azole antifungal indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum, among other approved uses. MedsAcross supplies Ketoconazole 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 KetoconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ketoconazole prescribing information (Ipg Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Ketoconazole Esteve (previously Ketoconazole HRA): European public assessment report (EPAR) · European Medicines Agency
Need Ketoconazole 200 mg tablet 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.