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    NDC 69315-0285-20 ETRAVIRINE 100 mg/1 Details

    ETRAVIRINE 100 mg/1

    ETRAVIRINE is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Leading Pharma, LLC. The primary component is ETRAVIRINE.

    Product Information

    NDC 69315-0285
    Product ID 69315-285_f356d1ba-3572-4a79-9846-94ee2030f04b
    Associated GPIs 12109035000320
    GCN Sequence Number 063597
    GCN Sequence Number Description etravirine TABLET 100 MG ORAL
    HIC3 W5K
    HIC3 Description ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI
    GCN 99318
    HICL Sequence Number 035342
    HICL Sequence Number Description ETRAVIRINE
    Brand/Generic Generic
    Proprietary Name ETRAVIRINE
    Proprietary Name Suffix n/a
    Non-Proprietary Name ETRAVIRINE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 100
    Active Ingredient Units mg/1
    Substance Name ETRAVIRINE
    Labeler Name Leading Pharma, LLC
    Pharmaceutical Class Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA215402
    Listing Certified Through 2025-12-31

    Package

    NDC 69315-0285-20 (69315028520)

    NDC Package Code 69315-285-20
    Billing NDC 69315028520
    Package 120 TABLET in 1 BOTTLE (69315-285-20)
    Marketing Start Date 2022-06-05
    NDC Exclude Flag N
    Pricing Information N/A