Medicine
Rufinamide 200 mg tablet
Rufinamide 200 mg tablet is a generic prescription medicine for oral use, made by 6 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 the tablets at 25 ° C (77 ° F), excursions permitted to 15 ° to 30 ° C…
Key facts
- Active ingredient (INN)
- Rufinamide
- Brand
- Sold under the generic name
- Strength
- 200 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 120 tablets, 30 tablets, 500 tablets and 6 more
- Manufacturers
- Glenmark PharmaceuticalsIndiaCamber PharmaceuticalsIndiaAurobindo PharmaIndiaLupinIndiaMicro LabsIndiaHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store the tablets at 25 ° C (77 ° F), excursions permitted to 15 ° to 30 ° C (59 ° F to 86 ° F). 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
- 16 May 2016
- Identifiers
- RxCUI 824295, 824301, 2612668DailyMed set ID 12fc41f9-b6a9-4bbd-afbe-5d269f5a42f6, d9ffc833-d902-41cb-8e8e-6bbba8e65b9e, da9ee326-a383-4d46-9d4e-fcc2be3d2680 +3NDC 42571-391, 59651-616, 68462-713 +3Application ANDA216688, ANDA217230, ANDA205075 +3
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 |
|---|---|---|---|
| 120 tablet, film coated in 1 bottle | 59651-616-08 | Aurobindo PharmaIndia | 16 June 2023 |
| 120 tablet, film coated in 1 bottle | 31722-598-12 | Camber PharmaceuticalsIndia | 11 May 2021 |
| 30 tablet, film coated in 1 bottle | 31722-598-30 | Camber PharmaceuticalsIndia | 11 May 2021 |
| 500 tablet, film coated in 1 bottle | 68462-713-05 | Glenmark PharmaceuticalsIndia | 16 May 2016 |
| 120 tablet, film coated in 1 bottle | 68462-713-08 | Glenmark PharmaceuticalsIndia | 16 May 2016 |
| 30 tablet, film coated in 1 bottle | 68462-713-30 | Glenmark PharmaceuticalsIndia | 16 May 2016 |
| 120 tablet, film coated in 1 bottle | 68180-803-16 | LupinIndia | 28 November 2022 |
| 120 tablet in 1 bottle | 42571-391-12 | Micro LabsIndia | 1 July 2023 |
| 120 tablet, film coated in 1 bottle | 0054-0425-23 | Hikma Pharmaceuticals | 30 May 2021 |
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 200 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 Rufinamide 200 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.