Medicine
Felbamate 400 mg tablet
Felbamate 400 mg tablet is a generic prescription medicine for oral use, made by 7 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)
- Felbamate
- Brand
- Sold under the generic name
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 18 more
- Manufacturers
- Viona PharmaceuticalsIndiaZydus LifesciencesIndiaSun Pharmaceutical IndustriesIndiaAmneal PharmaceuticalsAmneal Pharmaceuticals of New YorkBryant Ranch PrepackANI Pharmaceuticals
- 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
- N03AX10 Felbamate
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 September 2011
- Identifiers
- RxCUI 198358, 198359DailyMed set ID 17850520-f823-4d05-8f9b-5eadfa68bae2, 96f4357c-720c-4651-b638-7b1181531dc5, f2edb3ed-da20-4093-88ea-00fe781e47e0 +5NDC 62559-730, 72578-056, 51672-4185 +5Application ANDA202284, ANDA208970, ANDA207093 +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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 51672-4185-1 | Sun Pharmaceutical IndustriesIndia | 20 April 2017 |
| 30 tablet in 1 bottle | 51672-4185-6 | Sun Pharmaceutical IndustriesIndia | 20 April 2017 |
| 100 tablet in 1 bottle | 72578-056-01 | Viona PharmaceuticalsIndia | 3 March 2020 |
| 500 tablet in 1 bottle | 72578-056-05 | Viona PharmaceuticalsIndia | 3 March 2020 |
| 30 tablet in 1 bottle | 72578-056-06 | Viona PharmaceuticalsIndia | 3 March 2020 |
| 90 tablet in 1 bottle | 72578-056-16 | Viona PharmaceuticalsIndia | 3 March 2020 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 72578-056-77 | Viona PharmaceuticalsIndia | 3 March 2020 |
| 100 tablet in 1 bottle | 70771-1077-1 | Zydus LifesciencesIndia | 15 August 2017 |
| 30 tablet in 1 bottle | 70771-1077-3 | Zydus LifesciencesIndia | 15 August 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1077-4 | Zydus LifesciencesIndia | 15 August 2017 |
| 500 tablet in 1 bottle | 70771-1077-5 | Zydus LifesciencesIndia | 15 August 2017 |
| 90 tablet in 1 bottle | 70771-1077-9 | Zydus LifesciencesIndia | 15 August 2017 |
| 30 tablet in 1 bottle | 65162-734-03 | Amneal Pharmaceuticals | 16 September 2011 |
| 90 tablet in 1 bottle | 65162-734-09 | Amneal Pharmaceuticals | 16 September 2011 |
| 270 tablet in 1 bottle | 65162-734-27 | Amneal Pharmaceuticals | 16 September 2011 |
| 500 tablet in 1 bottle | 65162-734-50 | Amneal Pharmaceuticals | 16 September 2011 |
| 30 tablet in 1 bottle | 53746-734-30 | Amneal Pharmaceuticals of New York | 10 August 2022 |
| 90 tablet in 1 bottle | 53746-734-90 | Amneal Pharmaceuticals of New York | 10 August 2022 |
| 100 tablet in 1 bottle | 62559-730-01 | ANI Pharmaceuticals | 4 September 2018 |
| 100 tablet in 1 bottle | 63629-1937-1 | Bryant Ranch Prepack | 14 January 2021 |
| 100 tablet in 1 bottle | 72162-1770-1 | Bryant Ranch Prepack | 25 March 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 29 July 1993 | 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 Felbamate 400 mg tablet.
Other strengths and forms of Felbamate
Clinical summary
Felbamate is an anti-epileptic agent indicated as a first line antiepileptic treatment. It is available as tablets and oral suspension. MedsAcross supplies Felbamate 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 FelbamateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Felbatol prescribing information (Viatris Specialty) · U.S. National Library of Medicine, DailyMed
Need Felbamate 400 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.