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    NDC 64980-0406-03 Efavirenz 50 mg/1 Details

    Efavirenz 50 mg/1

    Efavirenz is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Rising Pharma Holdings, Inc.. The primary component is EFAVIRENZ.

    Product Information

    NDC 64980-0406
    Product ID 64980-406_ef5feaa1-6aff-47fc-9a9b-6ead5518b699
    Associated GPIs 12109030000110
    GCN Sequence Number 040655
    GCN Sequence Number Description efavirenz CAPSULE 50 MG ORAL
    HIC3 W5K
    HIC3 Description ANTIVIRALS, HIV-SPECIFIC, NON-NUCLEOSIDE, RTI
    GCN 43301
    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 CAPSULE
    Route ORAL
    Active Ingredient Strength 50
    Active Ingredient Units mg/1
    Substance Name EFAVIRENZ
    Labeler Name Rising Pharma Holdings, Inc.
    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 ANDA078064
    Listing Certified Through 2025-12-31

    Package

    NDC 64980-0406-03 (64980040603)

    NDC Package Code 64980-406-03
    Billing NDC 64980040603
    Package 30 CAPSULE in 1 BOTTLE (64980-406-03)
    Marketing Start Date 2017-12-15
    NDC Exclude Flag N
    Pricing Information N/A