NDC 43353-494

COUMADIN

Warfarin Sodium

COUMADIN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Inc.. The primary component is Warfarin Sodium.

Product ID43353-494_6e052f18-f7a6-4e8b-9222-0a12572960b6
NDC43353-494
Product TypeHuman Prescription Drug
Proprietary NameCOUMADIN
Generic NameWarfarin Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-01-01
Marketing CategoryNDA / NDA
Application NumberNDA009218
Labeler NameAphena Pharma Solutions - Tennessee, Inc.
Substance NameWARFARIN SODIUM
Active Ingredient Strength8 mg/1
Pharm ClassesVitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-494-30

30 TABLET in 1 BOTTLE, PLASTIC (43353-494-30)
Marketing Start Date2009-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-494-30 [43353049430]

COUMADIN TABLET
Marketing CategoryNDA
Application NumberNDA009218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
WARFARIN SODIUM7.5 mg/1

OpenFDA Data

SPL SET ID:ba41b963-ec4a-4421-ac93-26654876a6be
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855346
  • 855298
  • 855320
  • 855288
  • 855344
  • 855318
  • 855290
  • 855296

    • Pharmacological Class

    • Vitamin K Antagonist [EPC]
    • Vitamin K Inhibitors [MoA]

    NDC Crossover Matching brand name "COUMADIN" or generic name "Warfarin Sodium"

    NDCBrand NameGeneric Name
    0056-0168COUMADINwarfarin sodium
    0056-0169COUMADINwarfarin sodium
    0056-0170COUMADINwarfarin sodium
    0056-0172COUMADINwarfarin sodium
    0056-0173COUMADINwarfarin sodium
    0056-0174COUMADINwarfarin sodium
    0056-0176COUMADINwarfarin sodium
    0056-0188COUMADINwarfarin sodium
    0056-0189COUMADINwarfarin sodium
    43353-493COUMADINCOUMADIN
    43353-492COUMADINCOUMADIN
    43353-494COUMADINCOUMADIN
    43353-491COUMADINCOUMADIN
    50090-0028COUMADINCOUMADIN
    55154-7701COUMADINCOUMADIN
    55154-7706COUMADINCOUMADIN
    55154-7703COUMADINCOUMADIN
    55154-7704COUMADINCOUMADIN
    55154-7716COUMADINCOUMADIN
    55154-7702COUMADINCOUMADIN
    0093-1712Warfarin SodiumWarfarin Sodium
    0093-1713Warfarin SodiumWarfarin Sodium
    0093-1714Warfarin SodiumWarfarin Sodium
    0093-1715Warfarin SodiumWarfarin Sodium
    0093-1716Warfarin SodiumWarfarin Sodium

    Trademark Results [COUMADIN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COUMADIN
    COUMADIN
    71450506 0395328 Live/Registered
    Endo Products, Inc.
    1942-01-27
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