Search by Drug Name or NDC

    NDC 53002-1686-05 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 RPK Pharmaceuticals, Inc.. The primary component is RALTEGRAVIR POTASSIUM.

    Product Information

    NDC 53002-1686
    Product ID 53002-1686_8843daf4-719e-4ecf-b3fa-fd9eef8df018
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    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 RPK Pharmaceuticals, Inc.
    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 53002-1686-05 (53002168605)

    NDC Package Code 53002-1686-5
    Billing NDC 53002168605
    Package 15 TABLET, FILM COATED in 1 BOTTLE (53002-1686-5)
    Marketing Start Date 2022-01-01
    NDC Exclude Flag N
    Pricing Information N/A