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    NDC 00009-5093-01 Ellence 2 mg/mL Details

    Ellence 2 mg/mL

    Ellence is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Pharmacia & Upjohn Company LLC. The primary component is EPIRUBICIN HYDROCHLORIDE.

    Product Information

    NDC 00009-5093
    Product ID 0009-5093_27ab0561-e4f8-4db3-b1c5-dc22ccfdc5c6
    Associated GPIs 21200042102045
    GCN Sequence Number 061494
    GCN Sequence Number Description epirubicin HCl VIAL 200MG/0.1L INTRAVEN
    HIC3 V1D
    HIC3 Description ANTIBIOTIC ANTINEOPLASTICS
    GCN 97282
    HICL Sequence Number 006578
    HICL Sequence Number Description EPIRUBICIN HCL
    Brand/Generic Brand
    Proprietary Name Ellence
    Proprietary Name Suffix n/a
    Non-Proprietary Name epirubicin hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 2
    Active Ingredient Units mg/mL
    Substance Name EPIRUBICIN HYDROCHLORIDE
    Labeler Name Pharmacia & Upjohn Company LLC
    Pharmaceutical Class Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050778
    Listing Certified Through 2024-12-31

    Package

    NDC 00009-5093-01 (00009509301)

    NDC Package Code 0009-5093-01
    Billing NDC 00009509301
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-01) / 100 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 1999-09-15
    NDC Exclude Flag N
    Pricing Information N/A