NDC 68180-804

RUFINAMIDE

Rufinamide

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

Product ID68180-804_29588ca0-0dde-4a46-be19-0e58db8baa49
NDC68180-804
Product TypeHuman Prescription Drug
Proprietary NameRUFINAMIDE
Generic NameRufinamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-10-01
Marketing CategoryANDA /
Application NumberANDA204964
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameRUFINAMIDE
Active Ingredient Strength400 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68180-804-16

120 TABLET, FILM COATED in 1 BOTTLE (68180-804-16)
Marketing Start Date2022-10-01
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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