Skip to content
LookupMeds

Active ingredient

Rufinamide

24 finished FDA listings contain Rufinamide as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
RUFINAMIDE
Dosage forms
Suspension, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
12
Strengths listed
200 mg/1 · 40 mg/ml · 400 mg/1
Brand names in FDA listings
Banzel

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 69036

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021911EISAI INC2008-11-142
NDA 201367EISAI INC2011-03-031
ANDA 204988HIKMA2016-05-162
ANDA 205075GLENMARK PHARMS LTD2016-05-162
ANDA 211388BIONPHARMA2019-04-231
ANDA 207363HIKMA2019-04-232
ANDA 213457LUPIN2020-12-181
ANDA 213410ALKEM LABS LTD2021-02-231
ANDA 204993HETERO LABS LTD III2021-05-112
ANDA 204964LUPIN2022-08-172
ANDA 216549AUROBINDO PHARMA2022-10-261
ANDA 216688MICRO LABS2023-05-152
ANDA 217230AUROBINDO PHARMA2023-06-162
ANDA 216841HETERO LABS LTD III2023-12-052
ANDA 214817MSN2025-04-151

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.