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    NDC 63323-0883-30 Doxorubicin Hydrochloride 2 mg/mL Details

    Doxorubicin Hydrochloride 2 mg/mL

    Doxorubicin Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is DOXORUBICIN HYDROCHLORIDE.

    Product Information

    NDC 63323-0883
    Product ID 63323-883_9b008181-ab33-db2f-e053-2995a90aad57
    Associated GPIs 21200040102010
    GCN Sequence Number 061483
    GCN Sequence Number Description doxorubicin HCl VIAL 10 MG/5 ML INTRAVEN
    HIC3 V1D
    HIC3 Description ANTIBIOTIC ANTINEOPLASTICS
    GCN 97271
    HICL Sequence Number 003916
    HICL Sequence Number Description DOXORUBICIN HCL
    Brand/Generic Generic
    Proprietary Name Doxorubicin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name DOXORUBICIN HYDROCHLORIDE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 2
    Active Ingredient Units mg/mL
    Substance Name DOXORUBICIN HYDROCHLORIDE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA063277
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0883-30 (63323088330)

    NDC Package Code 63323-883-30
    Billing NDC 63323088330
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-30) / 25 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2000-04-14
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e0349f98-42fa-4003-b6d8-a1db1401b0ef Details

    Revised: 12/2019