NDC 42794-045

Dofetilide

Dofetilide

Dofetilide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sigmapharm Laboratories, Llc. The primary component is Dofetilide.

Product ID42794-045_6c45d21b-da17-2ee4-e053-2a91aa0a1881
NDC42794-045
Product TypeHuman Prescription Drug
Proprietary NameDofetilide
Generic NameDofetilide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-06-11
Marketing CategoryANDA / ANDA
Application NumberANDA207746
Labeler NameSigmapharm Laboratories, LLC
Substance NameDOFETILIDE
Active Ingredient Strength250 ug/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42794-045-10

60 CAPSULE in 1 BOTTLE, PLASTIC (42794-045-10)
Marketing Start Date2018-06-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42794-045-10 [42794004510]

Dofetilide CAPSULE
Marketing CategoryANDA
Application NumberANDA207746
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-11

Drug Details

Active Ingredients

IngredientStrength
DOFETILIDE250 ug/1

OpenFDA Data

SPL SET ID:0cb2ef7d-e35b-483b-9985-cfef99d7b96f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310004
  • 310005
  • 310003
  • UPC Code
  • 0342794046100
  • 0342794045103
  • 0342794044106
  • Pharmacological Class

    • Antiarrhythmic [EPC]

    Medicade Reported Pricing

    42794004510 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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