NDC 0054-0528

Rufinamide

Rufinamide

Rufinamide is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Rufinamide.

Product ID0054-0528_b615bd83-1b60-49cf-bd95-eb8c1f1015b8
NDC0054-0528
Product TypeHuman Prescription Drug
Proprietary NameRufinamide
Generic NameRufinamide
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2020-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA207363
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameRUFINAMIDE
Active Ingredient Strength40 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0054-0528-63

1 BOTTLE in 1 CARTON (0054-0528-63) > 460 mL in 1 BOTTLE
Marketing Start Date2020-11-01
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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