Medicine
Clotrimazole 10 mg/mL topical solution
Clotrimazole 10 mg/mL topical solution 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° to 25°C (68° to 77°F).
Key facts
- Active ingredient (INN)
- Clotrimazole
- Brand
- Sold under the generic name
- Strength
- 10 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 2 bottles and 8 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaScieGen PharmaceuticalsAkron PharmaAllegis HoldingsBryant Ranch PrepackNovitium PharmaPreferred PharmaceuticalsTruPharma
- 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
- A01AB18 Clotrimazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 July 1996
- Identifiers
- RxCUI 309370DailyMed set ID 15368c2a-572f-41fb-a3a1-7b1eb842faa8, 1d2354f2-edfd-4be7-9550-760958eb36ee, c64e2290-593f-48a2-a15d-41689f836fda +5NDC 50228-502, 52817-800, 68788-4155 +5Application ANDA216569, ANDA212281, ANDA074580 +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 bottle, plastic in 1 carton / 30 mL in 1 bottle, plastic | 51672-1260-3 | Sun Pharmaceutical IndustriesIndia | 29 July 1996 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 71399-0666-3 | Akron Pharma | 4 May 2024 |
| 2 bottle in 1 carton / 30 mL in 1 bottle | 71399-0666-6 | Akron Pharma | 25 March 2024 |
| 2 bottle in 1 carton / 10 mL in 1 bottle | 71297-030-02 | Allegis Holdings | 12 November 2025 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 70954-036-20 | Novitium Pharma | 18 February 2019 |
| 1 bottle in 1 carton / 10 mL in 1 bottle | 50228-502-08 | ScieGen Pharmaceuticals | 16 October 2023 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 50228-502-30 | ScieGen Pharmaceuticals | 16 October 2023 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 50228-502-31 | ScieGen Pharmaceuticals | 16 October 2023 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 52817-800-30 | TruPharma | 25 July 2019 |
| 1 bottle in 1 carton / 30 mL in 1 bottle | 72162-2178-3 | Bryant Ranch Prepack | 25 July 2019 |
| 1 bottle, plastic in 1 carton / 30 mL in 1 bottle, plastic | 68788-4155-3 | Preferred Pharmaceuticals | 16 July 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 3 February 1975 | 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 Clotrimazole
Clinical summary
Clotrimazole is an azole antifungal indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. MedsAcross supplies Clotrimazole 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 ClotrimazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CLOTIC (clotrimazole) otic solution prescribing information (Carwin Pharmaceutical Associates) · U.S. National Library of Medicine, DailyMed
Need Clotrimazole 10 mg/mL topical solution 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.