Medicine
Ketoconazole 20 mg/mL topical suspension
Ketoconazole 20 mg/mL topical suspension is a generic prescription medicine for topical use, made by 8 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 20-25°C (68-77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Ketoconazole
- Brand
- Sold under the generic name
- Strength
- 20 mg/mL
- Dosage form
- Topical suspension
- Route
- Topical
- Packs
- 120 mL, 118.28 mL and 10 more
- Manufacturers
- Bryant Ranch PrepackA-S Medication SolutionsNuCare Pharmaceuticals,IncPreferred PharmaceuticalsCosette PharmaceuticalsNorthStar RxPadagis Israel PharmaceuticalsProficient Rx
- Origin register
- US FDA, United States
- Storage
- Store at 20-25°C (68-77°F). Protect from light.
- 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
- 11 April 2005
- Identifiers
- RxCUI 106336DailyMed set ID 99da5233-2760-46f6-8fb3-d9df5da70bfb, b200ef76-5ea1-4253-bea5-1e8db0294510, 53492ad1-baca-a7f6-e063-6294a90a2990 +10NDC 45802-465, 63629-8675, 68071-5294 +10Application ANDA076419, ANDA076942
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 |
|---|---|---|---|
| 120 mL in 1 bottle, plastic | 0713-0592-04 | Cosette Pharmaceuticals | 7 February 2025 |
| 120 mL in 1 bottle | 45802-465-64 | Padagis Israel Pharmaceuticals | 19 January 2010 |
| 120 mL in 1 bottle | 63629-8675-1 | Bryant Ranch Prepack | 9 February 2022 |
| 120 mL in 1 bottle | 71335-2839-1 | Bryant Ranch Prepack | 24 October 2025 |
| 120 mL in 1 bottle | 72162-1409-2 | Bryant Ranch Prepack | 20 June 2024 |
| 118.28 mL in 1 bottle, plastic | 50090-3288-0 | A-S Medication Solutions | 30 November 2017 |
| 120 mL in 1 bottle, plastic | 50090-7538-0 | A-S Medication Solutions | 21 April 2025 |
| 120 mL in 1 bottle | 68071-3930-4 | NuCare Pharmaceuticals,Inc | 8 December 2025 |
| 120 mL in 1 bottle | 68071-5294-4 | NuCare Pharmaceuticals | 2 June 2026 |
| 120 mL in 1 bottle, plastic | 68788-8257-1 | Preferred Pharmaceuticals | 16 September 2022 |
| 120 mL in 1 bottle, plastic | 68788-8868-1 | Preferred Pharmaceuticals | 24 April 2025 |
| 120 mL in 1 bottle | 72603-878-01 | Northstar Rx | 1 December 2025 |
| 120 mL in 1 bottle, plastic | 71205-105-72 | Proficient Rx | 4 September 2018 |
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 20 mg/mL topical suspension 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.