Medicine
Terbinafine 250 mg tablet
Terbinafine 250 mg tablet is a generic prescription medicine for oral use, made by 22 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), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Terbinafine
- Brand
- Sold under the generic name
- Strength
- 250 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 500 tablets and 104 more
- Manufacturers
- CiplaIndiaDr. Reddy's LaboratoriesIndiaAurobindo PharmaIndiaBryant Ranch PrepackExelan PharmaceuticalsAmerisynAmici PharmaBionpharmaChartwell RXBreckenridge Pharmaceutical22 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). 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
- 2 July 2007
- Identifiers
- RxCUI 313222DailyMed set ID 294bc1af-50e3-4bff-8d48-321e673033ce, 8f87e3e1-4c9c-497a-af20-8ab52cfeef60, ab6f50a5-87ce-0819-e053-2a95a90a22b7 +37NDC 71335-1124, 16714-795, 51655-364 +37Application ANDA078297, ANDA077714, ANDA077137 +4
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
A sample of 40 packs from 22 labelers. The register lists 107 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet in 1 bottle | 69097-731-02 | CiplaIndia | 8 January 2021 |
| 100 tablet in 1 bottle | 69097-731-07 | CiplaIndia | 8 January 2021 |
| 30 tablet in 1 bottle | 69097-859-02 | CiplaIndia | 27 June 2016 |
| 100 tablet in 1 bottle | 69097-859-07 | CiplaIndia | 27 June 2016 |
| 500 tablet in 1 bottle | 69097-859-12 | CiplaIndia | 27 June 2016 |
| 100 tablet in 1 bottle | 65862-079-01 | Aurobindo PharmaIndia | 2 July 2007 |
| 30 tablet in 1 bottle | 65862-079-30 | Aurobindo PharmaIndia | 2 July 2007 |
| 1000 tablet in 1 bottle | 65862-079-99 | Aurobindo PharmaIndia | 2 July 2007 |
| 100 tablet in 1 bottle | 55111-250-01 | Dr. Reddy's LaboratoriesIndia | 2 July 2007 |
| 500 tablet in 1 bottle | 55111-250-05 | Dr. Reddy's LaboratoriesIndia | 2 July 2007 |
| 30 tablet in 1 bottle | 55111-250-30 | Dr. Reddy's LaboratoriesIndia | 2 July 2007 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 55111-250-79 | Dr. Reddy's LaboratoriesIndia | 2 July 2007 |
| 90 tablet in 1 bottle | 55111-250-90 | Dr. Reddy's LaboratoriesIndia | 2 July 2007 |
| 100 tablet in 1 bottle | 87564-010-10 | Amerisyn | 3 August 2026 |
| 30 tablet in 1 bottle | 87564-010-30 | Amerisyn | 3 August 2026 |
| 100 tablet in 1 bottle | 69292-225-01 | Amici Pharma | 18 February 2026 |
| 30 tablet in 1 bottle | 69292-225-30 | Amici Pharma | 18 February 2026 |
| 30 tablet in 1 bottle, plastic | 69452-351-13 | Bionpharma | 28 January 2022 |
| 100 tablet in 1 bottle, plastic | 69452-351-20 | Bionpharma | 28 January 2022 |
| 100 tablet in 1 bottle | 51991-526-01 | Breckenridge Pharmaceutical | 27 December 2010 |
| 30 tablet in 1 bottle | 62135-572-30 | Chartwell RX | 8 March 2022 |
| 90 tablet in 1 bottle | 62135-572-90 | Chartwell RX | 8 March 2022 |
| 100 tablet in 1 bottle | 76282-209-01 | Exelan Pharmaceuticals | 25 April 2012 |
| 500 tablet in 1 bottle | 76282-209-05 | Exelan Pharmaceuticals | 25 April 2012 |
| 30 tablet in 1 bottle | 76282-209-30 | Exelan Pharmaceuticals | 25 April 2012 |
| 30 tablet in 1 bottle | 71335-0918-1 | Bryant Ranch Prepack | 31 July 2018 |
| 60 tablet in 1 bottle | 71335-0918-2 | Bryant Ranch Prepack | 29 May 2024 |
| 90 tablet in 1 bottle | 71335-0918-3 | Bryant Ranch Prepack | 26 July 2022 |
| 100 tablet in 1 bottle | 71335-0918-4 | Bryant Ranch Prepack | 29 May 2024 |
| 7 tablet in 1 bottle | 71335-0918-5 | Bryant Ranch Prepack | 29 May 2024 |
| 40 tablet in 1 bottle | 71335-0918-6 | Bryant Ranch Prepack | 29 May 2024 |
| 45 tablet in 1 bottle | 71335-0918-7 | Bryant Ranch Prepack | 13 August 2018 |
| 14 tablet in 1 bottle | 71335-0918-8 | Bryant Ranch Prepack | 20 September 2018 |
| 28 tablet in 1 bottle | 71335-0918-9 | Bryant Ranch Prepack | 28 December 2021 |
| 30 tablet in 1 bottle | 71335-1124-1 | Bryant Ranch Prepack | 26 February 2019 |
| 60 tablet in 1 bottle | 71335-1124-2 | Bryant Ranch Prepack | 30 May 2024 |
| 90 tablet in 1 bottle | 71335-1124-3 | Bryant Ranch Prepack | 1 March 2021 |
| 100 tablet in 1 bottle | 71335-1124-4 | Bryant Ranch Prepack | 30 May 2024 |
| 7 tablet in 1 bottle | 71335-1124-5 | Bryant Ranch Prepack | 30 May 2024 |
| 40 tablet in 1 bottle | 71335-1124-6 | Bryant Ranch Prepack | 30 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 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 mg 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.