NDC 69452-223

Rufinamide

Rufinamide

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

Product ID69452-223_98bd1b77-c7fb-9921-e053-2995a90a1359
NDC69452-223
Product TypeHuman Prescription Drug
Proprietary NameRufinamide
Generic NameRufinamide
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2018-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA211388
Labeler NameBionpharma Inc.
Substance NameRUFINAMIDE
Active Ingredient Strength40 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69452-223-84

1 BOTTLE in 1 CARTON (69452-223-84) > 460 mL in 1 BOTTLE
Marketing Start Date2020-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-223-84 [69452022384]

Rufinamide SUSPENSION
Marketing CategoryANDA
Application NumberANDA211388
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-19
Marketing End Date2018-12-19

Drug Details

Active Ingredients

IngredientStrength
RUFINAMIDE40 mg/mL

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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