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    NDC 42291-0439-30 Emtricitabine and Tenofovir Disoproxil Fumarate 200; 300 mg/1; mg/1 Details

    Emtricitabine and Tenofovir Disoproxil Fumarate 200; 300 mg/1; mg/1

    Emtricitabine and 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 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 42291-0439
    Product ID 42291-439_0e8fcbb3-196e-92c2-e063-6294a90a392b
    Associated GPIs 12109902300320
    GCN Sequence Number 057883
    GCN Sequence Number Description emtricitabine/tenofovir (TDF) TABLET 200-300 MG ORAL
    HIC3 W5O
    HIC3 Description ANTIVIRALS, HIV-SPEC, NUCLEOSIDE-NUCLEOTIDE ANALOG
    GCN 23152
    HICL Sequence Number 026515
    HICL Sequence Number Description EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE
    Brand/Generic Generic
    Proprietary Name Emtricitabine and Tenofovir Disoproxil Fumarate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Emtricitabine and Tenofovir Disoproxil Fumarate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 200; 300
    Active Ingredient Units mg/1; mg/1
    Substance Name EMTRICITABINE; 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], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleosi
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209721
    Listing Certified Through 2025-12-31

    Package

    NDC 42291-0439-30 (42291043930)

    NDC Package Code 42291-439-30
    Billing NDC 42291043930
    Package 30 TABLET, FILM COATED in 1 BOTTLE (42291-439-30)
    Marketing Start Date 2021-03-30
    NDC Exclude Flag N
    Pricing Information N/A