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    NDC 60219-2095-03 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 Amneal Pharmaceuticals NY LLC. The primary component is EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 60219-2095
    Product ID 60219-2095_d5148a5e-b782-4d22-b1fb-e350648a9155
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 Amneal Pharmaceuticals NY LLC
    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 2024-12-31

    Package

    NDC 60219-2095-03 (60219209503)

    NDC Package Code 60219-2095-3
    Billing NDC 60219209503
    Package 30 TABLET, FILM COATED in 1 BOTTLE (60219-2095-3)
    Marketing Start Date 2018-08-26
    NDC Exclude Flag N
    Pricing Information N/A