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    NDC 68180-0287-01 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 Lupin Pharmaceuticals, Inc.. The primary component is EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 68180-0287
    Product ID 68180-287_1b7981ee-8124-46a2-9aab-f9b85d982650
    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 Lupin Pharmaceuticals, 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 ANDA204131
    Listing Certified Through 2024-12-31

    Package

    NDC 68180-0287-01 (68180028701)

    NDC Package Code 68180-287-01
    Billing NDC 68180028701
    Package 100 TABLET, FILM COATED in 1 BOTTLE (68180-287-01)
    Marketing Start Date 2021-06-23
    NDC Exclude Flag N
    Pricing Information N/A