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    NDC 70710-1367-09 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 Zydus Pharmaceuticals USA Inc.. The primary component is EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 70710-1367
    Product ID 70710-1367_aea4ca0a-a4ee-4895-ab93-010e118fa475
    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 Zydus Pharmaceuticals USA Inc.
    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 ANDA212689
    Listing Certified Through 2024-12-31

    Package

    NDC 70710-1367-09 (70710136709)

    NDC Package Code 70710-1367-9
    Billing NDC 70710136709
    Package 90 TABLET, FILM COATED in 1 BOTTLE (70710-1367-9)
    Marketing Start Date 2021-03-24
    NDC Exclude Flag N
    Pricing Information N/A