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    NDC 42385-0953-30 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 Laurus Labs Limited. The primary component is EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 42385-0953
    Product ID 42385-953_f87bdc93-cb49-4c2f-b8db-f8b8e57d0367
    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 Laurus Labs 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 ANDA212114
    Listing Certified Through 2024-12-31

    Package

    NDC 42385-0953-30 (42385095330)

    NDC Package Code 42385-953-30
    Billing NDC 42385095330
    Package 30 TABLET, FILM COATED in 1 BOTTLE (42385-953-30)
    Marketing Start Date 2019-07-26
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 0.59338
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description EMTRICITABINE-TENOFOVIR DISOPROXIL FUMARATE 200-300 MG TAB
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2024-02-21
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis