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    NDC 65862-0049-10 Efavirenz 600 mg/1 Details

    Efavirenz 600 mg/1

    Efavirenz 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 EFAVIRENZ.

    Product Information

    NDC 65862-0049
    Product ID 65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058
    Associated GPIs 12109030000330
    GCN Sequence Number 049849
    GCN Sequence Number Description efavirenz TABLET 600 MG ORAL
    HIC3 W5K
    HIC3 Description ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI
    GCN 15555
    HICL Sequence Number 018748
    HICL Sequence Number Description EFAVIRENZ
    Brand/Generic Generic
    Proprietary Name Efavirenz
    Proprietary Name Suffix n/a
    Non-Proprietary Name Efavirenz
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 600
    Active Ingredient Units mg/1
    Substance Name EFAVIRENZ
    Labeler Name Aurobindo Pharma 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], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcri
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077673
    Listing Certified Through 2025-12-31

    Package

    NDC 65862-0049-10 (65862004910)

    NDC Package Code 65862-049-10
    Billing NDC 65862004910
    Package 3 BLISTER PACK in 1 CARTON (65862-049-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
    Marketing Start Date 2018-09-21
    NDC Exclude Flag N
    Pricing Information N/A