Medicine
Clotrimazole 10 mg lozenge
Clotrimazole 10 mg lozenge is a generic prescription medicine for oral, topical use, 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
Avoid freezing. 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
- Dosage form
- Lozenge
- Route
- Oral, topical
- Packs
- 70 lozenges, 140 lozenges
- Manufacturer
- Hikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Avoid freezing. 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 2004
- Identifiers
- RxCUI 309371DailyMed set ID 0bc4b876-ddee-4f03-b44f-544348739a26NDC 0054-4146Application ANDA076387
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 |
|---|---|---|---|
| 70 lozenge in 1 bottle, plastic | 0054-4146-22 | Hikma Pharmacuticals | 29 July 2004 |
| 140 lozenge in 1 bottle, plastic | 0054-4146-23 | Hikma Pharmacuticals | 29 July 2004 |
| 140 lozenge in 1 bottle, plastic | 0574-0107-14 | — | 1 December 2005 |
| 70 lozenge in 1 bottle, plastic | 0574-0107-70 | — | 1 December 2005 |
| 70 packet in 1 box / 1 lozenge in 1 packet | 0574-0107-77 | — | 1 December 2005 |
| 70 lozenge in 1 bottle | 16571-686-07 | — | 1 May 2024 |
| 140 lozenge in 1 bottle | 16571-686-14 | — | 1 May 2024 |
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
Alternatives
Other makers and brands of Clotrimazole 10 mg lozenge.
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 lozenge 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.