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    NDC 60505-6228-00 Bendamustine Hydrochloride 25 mg/mL Details

    Bendamustine Hydrochloride 25 mg/mL

    Bendamustine Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp. The primary component is BENDAMUSTINE HYDROCHLORIDE.

    Product Information

    NDC 60505-6228
    Product ID 60505-6228_95e96765-57bc-fc7b-dee2-5e9000250196
    Associated GPIs
    GCN Sequence Number 075249
    GCN Sequence Number Description bendamustine HCl VIAL 25 MG/ML INTRAVEN
    HIC3 V1A
    HIC3 Description ANTINEOPLASTIC - ALKYLATING AGENTS
    GCN 40274
    HICL Sequence Number 016785
    HICL Sequence Number Description BENDAMUSTINE HCL
    Brand/Generic Generic
    Proprietary Name Bendamustine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Bendamustine Hydrochloride
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 25
    Active Ingredient Units mg/mL
    Substance Name BENDAMUSTINE HYDROCHLORIDE
    Labeler Name Apotex Corp
    Pharmaceutical Class Alkylating Activity [MoA], Alkylating Drug [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA215033
    Listing Certified Through 2024-12-31

    Package

    NDC 60505-6228-00 (60505622800)

    NDC Package Code 60505-6228-0
    Billing NDC 60505622800
    Package 1 VIAL, MULTI-DOSE in 1 CARTON (60505-6228-0) / 5 mL in 1 VIAL, MULTI-DOSE
    Marketing Start Date 2023-04-26
    NDC Exclude Flag N
    Pricing Information N/A