Medicine
Terbinafine 250 tablet
Terbinafine 250 tablet is a generic prescription medicine for oral 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
Store tablets at 20° to 25°C (68° F to 77°F), in a tight container. Protect…
Key facts
- Active ingredient (INN)
- Terbinafine
- Brand
- Sold under the generic name
- Strength
- 250
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 15 tablets, 30 tablets, 35 tablets and 3 more
- Manufacturer
- Proficient Rx
- Origin register
- US FDA, United States
- Storage
- Store tablets at 20° to 25°C (68° F to 77°F), in a tight container. Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D01AE15 Terbinafine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 27 June 2016
- Identifiers
- RxCUI 313222DailyMed set ID 3925dc10-ad66-46a8-bfa5-1a4314be3521NDC 71205-152Application ANDA077533
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
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 15 tablet in 1 bottle | 71205-152-15 | Proficient Rx | 1 November 2018 |
| 30 tablet in 1 bottle | 71205-152-30 | Proficient Rx | 1 November 2018 |
| 35 tablet in 1 bottle | 71205-152-35 | Proficient Rx | 1 November 2018 |
| 45 tablet in 1 bottle | 71205-152-45 | Proficient Rx | 1 November 2018 |
| 60 tablet in 1 bottle | 71205-152-60 | Proficient Rx | 1 November 2018 |
| 90 tablet in 1 bottle | 71205-152-90 | Proficient Rx | 1 November 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 30 December 1992 | 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 Terbinafine
Clinical summary
Terbinafine is an allylamine antifungal indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). It is available as tablets for oral use. MedsAcross supplies Terbinafine 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 TerbinafineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TERBINAFINE prescribing information (Amerisyn) · U.S. National Library of Medicine, DailyMed
Need Terbinafine 250 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.