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    NDC 42385-0928-30 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate 600; 300; 300 mg/1; mg/1; mg/1 Details

    Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate 600; 300; 300 mg/1; mg/1; mg/1

    Efavirenz, Lamivudine 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 EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE.

    Product Information

    NDC 42385-0928
    Product ID 42385-928_27623aed-629d-4406-a0bf-4f234fc4e6c6
    Associated GPIs 12109903330340
    GCN Sequence Number 078254
    GCN Sequence Number Description efavirenz/lamivu/tenofov disop TABLET 600-300 MG ORAL
    HIC3 W5Q
    HIC3 Description ARTV NUCLEOSIDE,NUCLEOTIDE,NON-NUCLEOSIDE RTI COMB
    GCN 44548
    HICL Sequence Number 044763
    HICL Sequence Number Description EFAVIRENZ/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE
    Brand/Generic Generic
    Proprietary Name Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 600; 300; 300
    Active Ingredient Units mg/1; mg/1; mg/1
    Substance Name EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
    Labeler Name Laurus Labs Limited
    Pharmaceutical Class Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA212786
    Listing Certified Through 2024-12-31

    Package

    NDC 42385-0928-30 (42385092830)

    NDC Package Code 42385-928-30
    Billing NDC 42385092830
    Package 30 TABLET, FILM COATED in 1 BOTTLE (42385-928-30)
    Marketing Start Date 2020-05-14
    NDC Exclude Flag N
    Pricing Information N/A