NDC 62856-583

Banzel

Rufinamide

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

Product ID62856-583_0ab0a8e5-ba46-496a-8f62-be8d95512d2d
NDC62856-583
Product TypeHuman Prescription Drug
Proprietary NameBanzel
Generic NameRufinamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-11-14
Marketing CategoryNDA / NDA
Application NumberNDA021911
Labeler NameEisai Inc.
Substance NameRUFINAMIDE
Active Ingredient Strength400 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62856-583-14

14 TABLET, FILM COATED in 1 BOTTLE (62856-583-14)
Marketing Start Date2018-08-08
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 62856-583-52 [62856058352]

Banzel TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021911
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-14

NDC 62856-583-14 [62856058314]

Banzel TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021911
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-08

Drug Details

Active Ingredients

IngredientStrength
RUFINAMIDE400 mg/1

OpenFDA Data

SPL SET ID:0a3fa925-1abd-458a-bd57-4ae780a1ef2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 824303
  • 824301
  • 1092360
  • 1092357
  • 824295
  • 824299
  • Medicade Reported Pricing

    62856058352 BANZEL 400 MG TABLET

    Pricing Unit: EA | Drug Type:

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

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

    Trademark Results [Banzel]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BANZEL
    BANZEL
    77334627 3613307 Live/Registered
    Eisai R&D Management Co., Ltd.
    2007-11-20

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