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    NDC 50090-1085-00 ISENTRESS 400 mg/1 Details

    ISENTRESS 400 mg/1

    ISENTRESS is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by A-S Medication Solutions. The primary component is RALTEGRAVIR POTASSIUM.

    Product Information

    NDC 50090-1085
    Product ID 50090-1085_fa8200b3-64ad-4ba4-a708-7a9b564d2ac8
    Associated GPIs 12103060100320
    GCN Sequence Number 063231
    GCN Sequence Number Description raltegravir potassium TABLET 400 MG ORAL
    HIC3 W5U
    HIC3 Description ANTIVIRALS,HIV-1 INTEGRASE STRAND TRANSFER INHIBTR
    GCN 98986
    HICL Sequence Number 035072
    HICL Sequence Number Description RALTEGRAVIR POTASSIUM
    Brand/Generic Generic
    Proprietary Name ISENTRESS
    Proprietary Name Suffix n/a
    Non-Proprietary Name RALTEGRAVIR
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, FILM COATED
    Route ORAL
    Active Ingredient Strength 400
    Active Ingredient Units mg/1
    Substance Name RALTEGRAVIR POTASSIUM
    Labeler Name A-S Medication Solutions
    Pharmaceutical Class HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA022145
    Listing Certified Through 2024-12-31

    Package

    NDC 50090-1085-00 (50090108500)

    NDC Package Code 50090-1085-0
    Billing NDC 50090108500
    Package 60 TABLET, FILM COATED in 1 BOTTLE (50090-1085-0)
    Marketing Start Date 2014-11-28
    NDC Exclude Flag N
    Pricing Information N/A