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    NDC 59651-0166-30 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 Aurobindo Pharma Limited. The primary component is EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 59651-0166
    Product ID 59651-166_a805c27a-1154-4aac-9af8-bbd755be027f
    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 133; 200
    Active Ingredient Units mg/1; mg/1
    Substance Name EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
    Labeler Name Aurobindo Pharma Limited
    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 ANDA211640
    Listing Certified Through 2025-12-31

    Package

    NDC 59651-0166-30 (59651016630)

    NDC Package Code 59651-166-30
    Billing NDC 59651016630
    Package 30 TABLET, FILM COATED in 1 BOTTLE (59651-166-30)
    Marketing Start Date 2023-03-09
    NDC Exclude Flag N
    Pricing Information N/A