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    NDC 61958-0501-01 Hepsera 10 mg/1 Details

    Hepsera 10 mg/1

    Hepsera is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Gilead Sciences, Inc.. The primary component is ADEFOVIR DIPIVOXIL.

    Product Information

    NDC 61958-0501
    Product ID 61958-0501_cdae0f96-628d-4f49-9970-a8557012ba94
    Associated GPIs 12352015100320
    GCN Sequence Number 050937
    GCN Sequence Number Description adefovir dipivoxil TABLET 10 MG ORAL
    HIC3 W5F
    HIC3 Description HEPATITIS B TREATMENT AGENTS
    GCN 18264
    HICL Sequence Number 024270
    HICL Sequence Number Description ADEFOVIR DIPIVOXIL
    Brand/Generic Brand
    Proprietary Name Hepsera
    Proprietary Name Suffix n/a
    Non-Proprietary Name adefovir dipivoxil
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name ADEFOVIR DIPIVOXIL
    Labeler Name Gilead Sciences, Inc.
    Pharmaceutical Class Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021449
    Listing Certified Through 2022-12-31

    Package

    NDC 61958-0501-01 (61958050101)

    NDC Package Code 61958-0501-1
    Billing NDC 61958050101
    Package 30 TABLET in 1 BOTTLE, PLASTIC (61958-0501-1)
    Marketing Start Date 2002-09-20
    NDC Exclude Flag N
    Pricing Information N/A