Medicine
Ketoconazole 2% cream
Ketoconazole 2% cream is a generic prescription medicine for topical use, made by 16 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)
- Ketoconazole
- Brand
- Sold under the generic name
- Strength
- 2%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 30 g, 15 tubes and 37 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaProficient RxA-S Medication SolutionsAsclemedE. FougeraEncube EthicalsGolden State Medical SupplyNorthStar RxSportpharmTeva Pharmaceuticals
- 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
- D01AC08 Ketoconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 18 December 2002
- Identifiers
- RxCUI 203088DailyMed set ID f422aaa8-3cce-5989-e053-2a95a90a5205, bf3e48fd-e063-42e6-acd1-580ddc6e93be, 750bcfc3-b0e4-407e-ad12-e81b183f3b00 +18NDC 72189-422, 16714-955, 50090-6046 +18Application ANDA212443, ANDA075638, ANDA075581 +1
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 |
|---|---|---|---|
| 1 tube in 1 carton / 15 g in 1 tube | 51672-1298-1 | Sun Pharmaceutical IndustriesIndia | 18 December 2002 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1298-2 | Sun Pharmaceutical IndustriesIndia | 18 December 2002 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1298-3 | Sun Pharmaceutical IndustriesIndia | 18 December 2002 |
| 1 tube in 1 carton / 15 g in 1 tube | 0168-0099-15 | E. Fougera | 28 April 2004 |
| 1 tube in 1 carton / 30 g in 1 tube | 0168-0099-30 | E. Fougera | 28 April 2004 |
| 1 tube in 1 carton / 60 g in 1 tube | 0168-0099-60 | E. Fougera | 28 April 2004 |
| 1 tube in 1 carton / 15 g in 1 tube | 21922-025-04 | Encube Ethicals | 27 May 2021 |
| 1 tube in 1 carton / 30 g in 1 tube | 21922-025-05 | Encube Ethicals | 27 May 2021 |
| 1 tube in 1 carton / 60 g in 1 tube | 21922-025-07 | Encube Ethicals | 27 May 2021 |
| 1 tube in 1 carton / 45 g in 1 tube | 71085-008-45 | Ipg Pharmaceuticals | 10 September 2026 |
| 1 tube in 1 carton / 15 g in 1 tube | 0093-3219-15 | Teva Pharmaceuticals | 8 February 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 0093-3219-30 | Teva Pharmaceuticals | 8 February 2019 |
| 1 tube in 1 carton / 60 g in 1 tube | 0093-3219-92 | Teva Pharmaceuticals | 8 February 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-5265-0 | A-S Medication Solutions | 16 October 2020 |
| 1 tube in 1 carton / 30 g in 1 tube | 50090-6046-0 | A-S Medication Solutions | 18 July 2022 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-6069-0 | A-S Medication Solutions | 12 September 2022 |
| 1 tube in 1 carton / 15 g in 1 tube | 63629-8819-1 | Bryant Ranch Prepack | 10 September 2021 |
| 1 tube in 1 carton / 60 g in 1 tube | 63629-8820-1 | Bryant Ranch Prepack | 10 September 2021 |
| 30 g in 1 box | 68071-1709-3 | NuCare Pharmaceuticals,Inc | 18 August 2017 |
| 15 tube in 1 carton / 15 g in 1 tube | 68071-3512-5 | NuCare Pharmaceuticals,Inc | 2 September 2023 |
| 1 tube in 1 carton / 15 g in 1 tube | 63187-774-15 | Proficient Rx | 1 November 2016 |
| 1 tube in 1 carton / 30 g in 1 tube | 63187-774-30 | Proficient Rx | 1 November 2016 |
| 1 tube in 1 carton / 60 g in 1 tube | 63187-774-60 | Proficient Rx | 1 November 2016 |
| 1 tube in 1 carton / 15 g in 1 tube | 82804-091-15 | Proficient Rx | 28 March 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 87063-066-15 | Asclemed | 20 January 2026 |
| 1 tube in 1 carton / 30 g in 1 tube | 87063-066-30 | Asclemed | 20 January 2026 |
| 1 tube in 1 carton / 60 g in 1 tube | 87063-066-60 | Asclemed | 20 January 2026 |
| 30 g in 1 tube | 72189-422-30 | Direct_Rx | 7 February 2023 |
| 1 tube in 1 carton / 15 g in 1 tube | 51407-279-15 | Golden State Medical Supply | 9 February 2020 |
| 1 tube in 1 carton / 30 g in 1 tube | 51407-279-30 | Golden State Medical Supply | 9 February 2020 |
| 1 tube in 1 carton / 60 g in 1 tube | 51407-279-60 | Golden State Medical Supply | 9 February 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 16714-955-01 | Northstar RX | 25 April 2019 |
| 1 tube in 1 carton / 30 g in 1 tube | 16714-955-02 | Northstar RX | 25 April 2019 |
| 1 tube in 1 carton / 60 g in 1 tube | 16714-955-03 | Northstar RX | 25 April 2019 |
| 1 tube in 1 carton / 15 g in 1 tube | 68788-8233-1 | Preferred Pharmaceuticals | 17 July 2023 |
| 1 tube in 1 carton / 30 g in 1 tube | 68788-8233-3 | Preferred Pharmaceuticals | 8 August 2022 |
| 1 tube in 1 carton / 30 g in 1 tube | 70518-4236-0 | Remedyrepack | 5 December 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 85766-135-15 | Sportpharm | 20 January 2026 |
| 1 tube in 1 carton / 30 g in 1 tube | 85766-135-30 | Sportpharm | 20 January 2026 |
| 1 tube in 1 carton / 60 g in 1 tube | 85766-135-60 | Sportpharm | 20 January 2026 |
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 2% cream 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.