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    NDC 76075-0103-01 KYPROLIS 10 mg/5mL Details

    KYPROLIS 10 mg/5mL

    KYPROLIS is a INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Onyx Pharmaceuticals, Inc.. The primary component is CARFILZOMIB.

    Product Information

    NDC 76075-0103
    Product ID 76075-103_703533f9-fc6c-4d67-bc41-40f99fb2e0df
    Associated GPIs 21536025002105
    GCN Sequence Number 076580
    GCN Sequence Number Description carfilzomib VIAL 10 MG INTRAVEN
    HIC3 V1Q
    HIC3 Description ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS
    GCN 42258
    HICL Sequence Number 039338
    HICL Sequence Number Description CARFILZOMIB
    Brand/Generic Brand
    Proprietary Name KYPROLIS
    Proprietary Name Suffix n/a
    Non-Proprietary Name carfilzomib
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 10
    Active Ingredient Units mg/5mL
    Substance Name CARFILZOMIB
    Labeler Name Onyx Pharmaceuticals, Inc.
    Pharmaceutical Class Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA202714
    Listing Certified Through 2024-12-31

    Package

    NDC 76075-0103-01 (76075010301)

    NDC Package Code 76075-103-01
    Billing NDC 76075010301
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (76075-103-01) / 10 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2018-05-23
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ea66eb30-e665-4693-99a1-a9d3b4bbe2d6 Details

    Revised: 6/2022