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    NDC 59651-0120-05 Dofetilide 0.5 mg/1 Details

    Dofetilide 0.5 mg/1

    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 Information

    NDC 59651-0120
    Product ID 59651-120_eb3e192c-26aa-42dd-8eae-2b8ee97dc021
    Associated GPIs 35400025000130
    GCN Sequence Number 044362
    GCN Sequence Number Description dofetilide CAPSULE 500 MCG ORAL
    HIC3 A2A
    HIC3 Description ANTIARRHYTHMICS
    GCN 92307
    HICL Sequence Number 020864
    HICL Sequence Number Description DOFETILIDE
    Brand/Generic Generic
    Proprietary Name Dofetilide
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dofetilide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 0.5
    Active Ingredient Units mg/1
    Substance Name DOFETILIDE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Antiarrhythmic [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210740
    Listing Certified Through 2024-12-31

    Package

    NDC 59651-0120-05 (59651012005)

    NDC Package Code 59651-120-05
    Billing NDC 59651012005
    Package 500 CAPSULE in 1 BOTTLE (59651-120-05)
    Marketing Start Date 2019-01-22
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 85f2b35c-31d5-4161-b342-c781d23945a5 Details

    Revised: 4/2021