NDC 51862-125

Dofetilide

Dofetilide

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

Product ID51862-125_35cc8a01-96fa-43ab-8429-72396c201edd
NDC51862-125
Product TypeHuman Prescription Drug
Proprietary NameDofetilide
Generic NameDofetilide
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-06-07
Marketing CategoryANDA / ANDA
Application NumberANDA207058
Labeler NameMayne Pharma Inc.
Substance NameDOFETILIDE
Active Ingredient Strength0 mg/1
Pharm ClassesAntiarrhythmic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51862-125-60

60 CAPSULE in 1 BOTTLE, PLASTIC (51862-125-60)
Marketing Start Date2016-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-125-14 [51862012514]

Dofetilide CAPSULE
Marketing CategoryANDA
Application NumberANDA207058
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-07
Marketing End Date2017-07-17

NDC 51862-125-60 [51862012560]

Dofetilide CAPSULE
Marketing CategoryANDA
Application NumberANDA207058
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-06-07

Drug Details

Active Ingredients

IngredientStrength
DOFETILIDE.125 mg/1

OpenFDA Data

SPL SET ID:a806d3d2-d4c1-461c-b2e4-8807bfb59cb8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310004
  • 310005
  • 310003
  • UPC Code
  • 0351862025602
  • Pharmacological Class

    • Antiarrhythmic [EPC]

    Medicade Reported Pricing

    51862012560 DOFETILIDE 125 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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