NDC 47335-062

DOFETILIDE

Dofetilide

DOFETILIDE is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Dofetilide.

Product ID47335-062_343947d7-7024-4ad4-8577-5922306d23b1
NDC47335-062
Product TypeHuman Prescription Drug
Proprietary NameDOFETILIDE
Generic NameDofetilide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-10-11
Marketing CategoryANDA / ANDA
Application NumberANDA210466
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameDOFETILIDE
Active Ingredient Strength0 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 47335-062-79

4 BLISTER PACK in 1 CARTON (47335-062-79) > 10 CAPSULE in 1 BLISTER PACK (47335-062-66)
Marketing Start Date2018-10-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-062-79 [47335006279]

DOFETILIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA210466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-11

NDC 47335-062-66 [47335006266]

DOFETILIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA210466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-11

NDC 47335-062-86 [47335006286]

DOFETILIDE CAPSULE
Marketing CategoryANDA
Application NumberANDA210466
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-11

Drug Details

Active Ingredients

IngredientStrength
DOFETILIDE.25 mg/1

OpenFDA Data

SPL SET ID:e6caaf44-4a3e-46ef-85fa-f97f682fbdd6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310004
  • 310005
  • 310003
    • UPC Code
  • 0347335061864
  • 0347335063868
  • 0347335062861

    • Pharmacological Class

    • Antiarrhythmic [EPC]

    Medicade Reported Pricing

    47335006286 DOFETILIDE 250 MCG CAPSULE

    Pricing Unit: EA | Drug Type:

    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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