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    NDC 59651-0086-30 Darunavir 800 mg/1 Details

    Darunavir 800 mg/1

    Darunavir 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 DARUNAVIR PROPYLENE GLYCOLATE.

    Product Information

    NDC 59651-0086
    Product ID 59651-086_88910ad0-6dc3-4a47-8a6b-5c6ee79f2a93
    Associated GPIs
    GCN Sequence Number 070245
    GCN Sequence Number Description darunavir TABLET 800 MG ORAL
    HIC3 W5P
    HIC3 Description ANTIVIRALS, HIV-SPEC, NON-PEPTIDIC PROTEASE INHIB
    GCN 33723
    HICL Sequence Number 033842
    HICL Sequence Number Description DARUNAVIR
    Brand/Generic Generic
    Proprietary Name Darunavir
    Proprietary Name Suffix n/a
    Non-Proprietary Name Darunavir
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 800
    Active Ingredient Units mg/1
    Substance Name DARUNAVIR PROPYLENE GLYCOLATE
    Labeler Name Aurobindo Pharma Limited
    Pharmaceutical Class Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210677
    Listing Certified Through 2024-12-31

    Package

    NDC 59651-0086-30 (59651008630)

    NDC Package Code 59651-086-30
    Billing NDC 59651008630
    Package 30 TABLET, FILM COATED in 1 BOTTLE (59651-086-30)
    Marketing Start Date 2023-11-28
    NDC Exclude Flag N
    Pricing Information N/A