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    NDC 68001-0345-26 Doxorubicin Hydrochloride 2 mg/mL Details

    Doxorubicin Hydrochloride 2 mg/mL

    Doxorubicin Hydrochloride is a INTRAVENOUS INJECTABLE, LIPOSOMAL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BluePoint Laboratories. The primary component is DOXORUBICIN HYDROCHLORIDE.

    Product Information

    NDC 68001-0345
    Product ID 68001-345_e9b9ead5-4033-1599-e053-2a95a90a0d81
    Associated GPIs 21200040402210
    GCN Sequence Number 024447
    GCN Sequence Number Description doxorubicin HCl peg-liposomal VIAL 2 MG/ML INTRAVEN
    HIC3 V1D
    HIC3 Description ANTIBIOTIC ANTINEOPLASTICS
    GCN 47343
    HICL Sequence Number 010222
    HICL Sequence Number Description DOXORUBICIN HCL PEGYLATED LIPOSOMAL
    Brand/Generic Generic
    Proprietary Name Doxorubicin Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Doxorubicin Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTABLE, LIPOSOMAL
    Route INTRAVENOUS
    Active Ingredient Strength 2
    Active Ingredient Units mg/mL
    Substance Name DOXORUBICIN HYDROCHLORIDE
    Labeler Name BluePoint Laboratories
    Pharmaceutical Class Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208657
    Listing Certified Through 2024-12-31

    Package

    NDC 68001-0345-26 (68001034526)

    NDC Package Code 68001-345-26
    Billing NDC 68001034526
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-345-26) / 25 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2018-02-16
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL f1a12eb5-5bdc-45f4-843e-0c971535b184 Details

    Revised: 9/2022