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    NDC 15054-0043-01 Onivyde 4.3 mg/mL Details

    Onivyde 4.3 mg/mL

    Onivyde is a INTRAVENOUS INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Ipsen Biopharmaceuticals, Inc.. The primary component is IRINOTECAN HYDROCHLORIDE.

    Product Information

    NDC 15054-0043
    Product ID 15054-0043_5ecd8e9a-b782-47f8-b5de-f19d3f14ebdc
    Associated GPIs 21550040202220
    GCN Sequence Number 075024
    GCN Sequence Number Description irinotecan liposomal VIAL 43 MG/10ML INTRAVEN
    HIC3 V3E
    HIC3 Description ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS
    GCN 39929
    HICL Sequence Number 042715
    HICL Sequence Number Description IRINOTECAN LIPOSOMAL
    Brand/Generic Brand
    Proprietary Name Onivyde
    Proprietary Name Suffix n/a
    Non-Proprietary Name IRINOTECAN HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 4.3
    Active Ingredient Units mg/mL
    Substance Name IRINOTECAN HYDROCHLORIDE
    Labeler Name Ipsen Biopharmaceuticals, Inc.
    Pharmaceutical Class Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA207793
    Listing Certified Through 2024-12-31

    Package

    NDC 15054-0043-01 (15054004301)

    NDC Package Code 15054-0043-1
    Billing NDC 15054004301
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2015-10-22
    NDC Exclude Flag N
    Pricing Information N/A