Search by Drug Name or NDC

    NDC 43598-0704-05 Darunavir 600 mg/1 Details

    Darunavir 600 mg/1

    Darunavir is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Dr.Reddys Laboratories Inc. The primary component is DARUNAVIR.

    Product Information

    NDC 43598-0704
    Product ID 43598-704_82f022df-8075-b1cd-f33b-a5603365dcc2
    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
    Proprietary Name Suffix n/a
    Non-Proprietary Name Darunavir
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 600
    Active Ingredient Units mg/1
    Substance Name DARUNAVIR
    Labeler Name Dr.Reddys Laboratories 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 ANDA211578
    Listing Certified Through 2024-12-31

    Package

    NDC 43598-0704-05 (43598070405)

    NDC Package Code 43598-704-05
    Billing NDC 43598070405
    Package 500 TABLET, FILM COATED in 1 BOTTLE (43598-704-05)
    Marketing Start Date 2023-11-29
    NDC Exclude Flag N
    Pricing Information N/A