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    NDC 63323-0721-10 Bortezomib 1 mg/mL Details

    Bortezomib 1 mg/mL

    Bortezomib is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is BORTEZOMIB.

    Product Information

    NDC 63323-0721
    Product ID 63323-721_81e8728c-5928-4029-8aa0-0e7f761af75a
    Associated GPIs 21536015002122
    GCN Sequence Number 078005
    GCN Sequence Number Description bortezomib VIAL 3.5 MG INTRAVEN
    HIC3 V1Q
    HIC3 Description ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
    GCN 44204
    HICL Sequence Number 025202
    HICL Sequence Number Description BORTEZOMIB
    Brand/Generic Generic
    Proprietary Name Bortezomib
    Proprietary Name Suffix n/a
    Non-Proprietary Name Bortezomib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 1
    Active Ingredient Units mg/mL
    Substance Name BORTEZOMIB
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA205004
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0721-10 (63323072110)

    NDC Package Code 63323-721-10
    Billing NDC 63323072110
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-721-10) / 10 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2017-11-06
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 042329d6-8077-4af2-816f-cd0a2bbcbbd3 Details

    Revised: 4/2022