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    NDC 72266-0235-01 Dexrazoxane 250 mg/25mL Details

    Dexrazoxane 250 mg/25mL

    Dexrazoxane is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fosun Pharma USA Inc.. The primary component is DEXRAZOXANE HYDROCHLORIDE.

    Product Information

    NDC 72266-0235
    Product ID 72266-235_e15ad0ae-009a-ea57-e053-2995a90a0ab5
    Associated GPIs 21754040102120
    GCN Sequence Number 072983
    GCN Sequence Number Description dexrazoxane HCl VIAL 250 MG INTRAVEN
    HIC3 V1I
    HIC3 Description CHEMOTHERAPY RESCUE/ANTIDOTE AGENTS
    GCN 37295
    HICL Sequence Number 016635
    HICL Sequence Number Description DEXRAZOXANE HCL
    Brand/Generic Generic
    Proprietary Name Dexrazoxane
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dexrazoxane for Injection
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 250
    Active Ingredient Units mg/25mL
    Substance Name DEXRAZOXANE HYDROCHLORIDE
    Labeler Name Fosun Pharma USA Inc.
    Pharmaceutical Class Cytoprotective Agent [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207321
    Listing Certified Through 2024-12-31

    Package

    NDC 72266-0235-01 (72266023501)

    NDC Package Code 72266-235-01
    Billing NDC 72266023501
    Package 1 VIAL in 1 CARTON (72266-235-01) / 25 mL in 1 VIAL
    Marketing Start Date 2021-11-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL c1d98fbe-5fd9-4518-b1a5-fac92e32928f Details

    Revised: 6/2022