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    NDC 42291-0800-30 Tenofovir Disoproxil Fumarate 300 mg/1 Details

    Tenofovir Disoproxil Fumarate 300 mg/1

    Tenofovir Disoproxil Fumarate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 42291-0800
    Product ID 42291-800_0e9aa072-4597-d186-e063-6394a90a21e2
    Associated GPIs 12108570100320
    GCN Sequence Number 048843
    GCN Sequence Number Description tenofovir disoproxil fumarate TABLET 300 MG ORAL
    HIC3 W5I
    HIC3 Description ANTIVIRALS, HIV-SPECIFIC, NUCLEOTIDE ANALOG, RTI
    GCN 14822
    HICL Sequence Number 022937
    HICL Sequence Number Description TENOFOVIR DISOPROXIL FUMARATE
    Brand/Generic Generic
    Proprietary Name Tenofovir Disoproxil Fumarate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Tenofovir Disoproxil Fumarate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 300
    Active Ingredient Units mg/1
    Substance Name TENOFOVIR DISOPROXIL FUMARATE
    Labeler Name AvKARE
    Pharmaceutical Class Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090636
    Listing Certified Through 2025-12-31

    Package

    NDC 42291-0800-30 (42291080030)

    NDC Package Code 42291-800-30
    Billing NDC 42291080030
    Package 30 TABLET, FILM COATED in 1 BOTTLE (42291-800-30)
    Marketing Start Date 2019-01-10
    NDC Exclude Flag N
    Pricing Information N/A