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    NDC 42385-0921-48 Atazanavir 200 mg/1 Details

    Atazanavir 200 mg/1

    Atazanavir is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Laurus Labs Limited. The primary component is ATAZANAVIR SULFATE.

    Product Information

    NDC 42385-0921
    Product ID 42385-921_7d442858-8287-43ad-9bf7-990b1f3665be
    Associated GPIs 12104515200140
    GCN Sequence Number 052748
    GCN Sequence Number Description atazanavir sulfate CAPSULE 200 MG ORAL
    HIC3 W5C
    HIC3 Description ANTIVIRALS, HIV-SPECIFIC, PROTEASE INHIBITORS
    GCN 19953
    HICL Sequence Number 025390
    HICL Sequence Number Description ATAZANAVIR SULFATE
    Brand/Generic Generic
    Proprietary Name Atazanavir
    Proprietary Name Suffix n/a
    Non-Proprietary Name Atazanavir
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/1
    Substance Name ATAZANAVIR SULFATE
    Labeler Name Laurus Labs Limited
    Pharmaceutical Class Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA212579
    Listing Certified Through 2024-12-31

    Package

    NDC 42385-0921-48 (42385092148)

    NDC Package Code 42385-921-48
    Billing NDC 42385092148
    Package 10 BLISTER PACK in 1 CARTON (42385-921-48) / 6 CAPSULE in 1 BLISTER PACK (42385-921-06)
    Marketing Start Date 2021-04-30
    NDC Exclude Flag N
    Pricing Information N/A