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    NDC 00003-3756-14 OPDIVO 10 mg/mL Details

    OPDIVO 10 mg/mL

    OPDIVO is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E.R. Squibb & Sons, L.L.C.. The primary component is NIVOLUMAB.

    Product Information

    NDC 00003-3756
    Product ID 0003-3756_14db8181-5332-4374-8278-53b726994528
    Associated GPIs 21357941002033
    GCN Sequence Number 082624
    GCN Sequence Number Description nivolumab VIAL 120MG/12ML INTRAVEN
    HIC3 V3R
    HIC3 Description ANTINEOPLASTIC,ANTI-PROGRAMMED DEATH-1 (PD-1) MAB
    GCN 50434
    HICL Sequence Number 041654
    HICL Sequence Number Description NIVOLUMAB
    Brand/Generic Brand
    Proprietary Name OPDIVO
    Proprietary Name Suffix n/a
    Non-Proprietary Name nivolumab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 10
    Active Ingredient Units mg/mL
    Substance Name NIVOLUMAB
    Labeler Name E.R. Squibb & Sons, L.L.C.
    Pharmaceutical Class Programmed Death Receptor-1 Blocking Antibody [EPC], Programmed Death Receptor-1-directed Antibody Interactions [MoA]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125554
    Listing Certified Through 2024-12-31

    Package

    NDC 00003-3756-14 (00003375614)

    NDC Package Code 0003-3756-14
    Billing NDC 00003375614
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (0003-3756-14) / 12 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2021-08-30
    NDC Exclude Flag N
    Pricing Information N/A