NDC 59651-119

Dofetilide

Dofetilide

Dofetilide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Dofetilide.

Product ID59651-119_0ccd8a3a-e480-4c66-b96a-30b8c1870639
NDC59651-119
Product TypeHuman Prescription Drug
Proprietary NameDofetilide
Generic NameDofetilide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-01-22
Marketing CategoryANDA / ANDA
Application NumberANDA210740
Labeler NameAurobindo Pharma Limited
Substance NameDOFETILIDE
Active Ingredient Strength0 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59651-119-05

500 CAPSULE in 1 BOTTLE (59651-119-05)
Marketing Start Date2019-01-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59651-119-05 [59651011905]

Dofetilide CAPSULE
Marketing CategoryANDA
Application NumberANDA210740
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-22

NDC 59651-119-60 [59651011960]

Dofetilide CAPSULE
Marketing CategoryANDA
Application NumberANDA210740
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-22

Drug Details

Active Ingredients

IngredientStrength
DOFETILIDE.25 mg/1

OpenFDA Data

SPL SET ID:85f2b35c-31d5-4161-b342-c781d23945a5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310004
  • 310005
  • 310003
  • Pharmacological Class

    • Antiarrhythmic [EPC]

    NDC Crossover Matching brand name "Dofetilide" or generic name "Dofetilide"

    NDCBrand NameGeneric Name
    0904-6681DofetilideDofetilide
    0904-6682DofetilideDofetilide
    0904-6683DofetilideDofetilide
    16714-840DofetilideDofetilide
    16714-841DofetilideDofetilide
    16714-842DofetilideDofetilide
    16729-490DofetilideDofetilide
    16729-491DofetilideDofetilide
    16729-492DofetilideDofetilide
    42291-411DofetilideDofetilide
    42291-412DofetilideDofetilide
    42291-413DofetilideDofetilide
    69452-132DofetilideDofetilide
    69452-133DofetilideDofetilide
    69452-131DofetilideDofetilide
    42794-045DofetilideDofetilide
    42794-044DofetilideDofetilide
    42794-046DofetilideDofetilide
    47335-061DOFETILIDEDOFETILIDE
    47335-062DOFETILIDEDOFETILIDE
    47335-063DOFETILIDEDOFETILIDE
    51862-025DofetilideDofetilide
    51862-125DofetilideDofetilide
    51862-005DofetilideDofetilide
    59762-0037DofetilideDofetilide
    59762-0038DofetilideDofetilide
    59651-119DofetilideDofetilide
    59651-118DofetilideDofetilide
    59651-120DofetilideDofetilide
    59762-0039DofetilideDofetilide
    71410-301DofetilideDofetilide
    71410-300DofetilideDofetilide
    71410-302DofetilideDofetilide
    0069-5800Tikosyndofetilide
    0069-5810Tikosyndofetilide
    0069-5820Tikosyndofetilide

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