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    NDC 69097-0248-03 Darunavir 600 and 800 mg 600 mg/1 Details

    Darunavir 600 and 800 mg 600 mg/1

    Darunavir 600 and 800 mg is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is DARUNAVIR HYDRATE.

    Product Information

    NDC 69097-0248
    Product ID 69097-248_bdbfc235-3cca-4fa0-be70-9c34cfb91feb
    Associated GPIs
    GCN Sequence Number 063719
    GCN Sequence Number Description darunavir TABLET 600 MG ORAL
    HIC3 W5P
    HIC3 Description ANTIVIRALS, HIV-SPEC, NON-PEPTIDIC PROTEASE INHIB
    GCN 99434
    HICL Sequence Number 033842
    HICL Sequence Number Description DARUNAVIR
    Brand/Generic Generic
    Proprietary Name Darunavir 600 and 800 mg
    Proprietary Name Suffix n/a
    Non-Proprietary Name darunavir
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 600
    Active Ingredient Units mg/1
    Substance Name DARUNAVIR HYDRATE
    Labeler Name Cipla USA Inc.
    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 ANDA206288
    Listing Certified Through 2024-12-31

    Package

    NDC 69097-0248-03 (69097024803)

    NDC Package Code 69097-248-03
    Billing NDC 69097024803
    Package 60 TABLET in 1 BOTTLE (69097-248-03)
    Marketing Start Date 2023-11-29
    NDC Exclude Flag N
    Pricing Information
    Price Per Unit 3.74957
    Pricing Unit EA
    Effective Date 2024-02-21
    NDC Description DARUNAVIR 600 MG TABLET
    Pharmacy Type Indicator C/I
    OTC N
    Explanation Code 1
    Classification for Rate Setting G
    As of Date 2024-02-21
    This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis