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    NDC 61703-0349-09 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 Hospira, Inc.. The primary component is IRINOTECAN HYDROCHLORIDE.

    Product Information

    NDC 61703-0349
    Product ID 61703-349_97675447-8e56-4d7d-a8ab-677b2897fab0
    Associated GPIs 21550040102030 21550040102025 21550040102040
    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 Hospira, Inc.
    Pharmaceutical Class Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA077915
    Listing Certified Through 2024-12-31

    Package

    NDC 61703-0349-09 (61703034909)

    NDC Package Code 61703-349-09
    Billing NDC 61703034909
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-09) / 5 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2008-02-27
    NDC Exclude Flag N
    Pricing Information N/A