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    NDC 70710-1365-04 Emtricitabine and tenofovir disoproxil fumarate 133; 200 mg/1; mg/1 Details

    Emtricitabine and tenofovir disoproxil fumarate 133; 200 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 70710-1365
    Product ID 70710-1365_aea4ca0a-a4ee-4895-ab93-010e118fa475
    Associated GPIs 12109902300312
    GCN Sequence Number 076101
    GCN Sequence Number Description emtricitabine/tenofovir (TDF) TABLET 133-200 MG ORAL
    HIC3 W5O
    HIC3 Description ANTIVIRALS, HIV-SPEC, NUCLEOSIDE-NUCLEOTIDE ANALOG
    GCN 41375
    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 133; 200
    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 70710-1365-04 (70710136504)

    NDC Package Code 70710-1365-4
    Billing NDC 70710136504
    Package 10 BLISTER PACK in 1 CARTON (70710-1365-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70710-1365-2)
    Marketing Start Date 2021-07-01
    NDC Exclude Flag N
    Pricing Information N/A