Banzel 400 mg tablet is a prescription medicine containing Rufinamide for oral use, marketed by Eisai, 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 the tablets at 25ºC (77ºF), excursions permitted to 15º- 30ºC (59ºF -…
Key facts
- Active ingredient (INN)
- Rufinamide
- Brand
- Banzel
- Strength
- 400 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets
- Marketing authorisation holder
- Eisai
- Manufacturer
- Eisai
- Origin register
- US FDA, United States
- Storage
- Store the tablets at 25ºC (77ºF), excursions permitted to 15º- 30ºC (59ºF - 86ºF). Store the oral suspension at 25ºC (77ºF), excursions permitted to 15º- 30ºC (59ºF - 86ºF). Protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N03AF03 Rufinamide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 November 2008
- Identifiers
- RxCUI 824295, 824299, 824301 +3DailyMed set ID 0a3fa925-1abd-458a-bd57-4ae780a1ef2dNDC 62856-583Application NDA021911
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 |
|---|---|---|---|
| 120 tablet, film coated in 1 bottle | 62856-583-52 | Eisai | 14 November 2008 |
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.
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 Rufinamide 400 mg tablet.
Other strengths and forms of Rufinamide
Clinical summary
Rufinamide is a prescription medicine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. It is available as tablets and oral suspension. MedsAcross supplies Rufinamide 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 RufinamideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Banzel prescribing information (Eisai) · U.S. National Library of Medicine, DailyMed
- Inovelon: European public assessment report (EPAR) · European Medicines Agency
Need Banzel 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.