NDC 0378-2331

Rufinamide

Rufinamide

Rufinamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Rufinamide.

Product ID0378-2331_62ccf656-3985-4867-9ad7-a21b711e3215
NDC0378-2331
Product TypeHuman Prescription Drug
Proprietary NameRufinamide
Generic NameRufinamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2021-06-01
Marketing CategoryANDA /
Application NumberANDA205095
Labeler NameMylan Pharmaceuticals Inc.
Substance NameRUFINAMIDE
Active Ingredient Strength400 mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-2331-78

120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2331-78)
Marketing Start Date2021-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Rufinamide" or generic name "Rufinamide"

NDCBrand NameGeneric Name
0054-0425RufinamideRufinamide
0054-0426RufinamideRufinamide
0054-0528RufinamideRufinamide
0378-2330Rufinamiderufinamide
0378-2331Rufinamiderufinamide
31722-598RufinamideRufinamide
31722-599RufinamideRufinamide
59651-563RUFINAMIDERUFINAMIDE
60687-643RufinamideRufinamide
67877-673RufinamideRufinamide
68180-797RufinamideRufinamide
68180-802RUFINAMIDErufinamide
68180-803RUFINAMIDErufinamide
69452-223RufinamideRufinamide
62856-582Banzelrufinamide
62856-583Banzelrufinamide
62856-584Banzelrufinamide

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