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    NDC 60505-6272-01 Irinotecan Hydrochloride 20 mg/mL Details

    Irinotecan Hydrochloride 20 mg/mL

    Irinotecan Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is IRINOTECAN HYDROCHLORIDE.

    Product Information

    NDC 60505-6272
    Product ID 60505-6272_3bd941f7-1566-4b52-8b1f-48b2636deff6
    Associated GPIs
    GCN Sequence Number 062174
    GCN Sequence Number Description irinotecan HCl VIAL 100 MG/5ML INTRAVEN
    HIC3 V3E
    HIC3 Description ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS
    GCN 97956
    HICL Sequence Number 010778
    HICL Sequence Number Description IRINOTECAN HCL
    Brand/Generic Generic
    Proprietary Name Irinotecan Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Irinotecan Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 20
    Active Ingredient Units mg/mL
    Substance Name IRINOTECAN HYDROCHLORIDE
    Labeler Name Apotex Corp.
    Pharmaceutical Class Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203380
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-6272-01 (60505627201)

    NDC Package Code 60505-6272-1
    Billing NDC 60505627201
    Package 1 VIAL, SINGLE-USE in 1 CARTON (60505-6272-1) / 5 mL in 1 VIAL, SINGLE-USE
    Marketing Start Date 2023-07-01
    NDC Exclude Flag N
    Pricing Information N/A