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    NDC 57894-0350-89 SIMPONI ARIA 50 mg/4mL Details

    SIMPONI ARIA 50 mg/4mL

    SIMPONI ARIA is a INTRAVENOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is GOLIMUMAB.

    Product Information

    NDC 57894-0350
    Product ID 57894-350_00d8fc3f-a495-cd29-e063-6294a90a976d
    Associated GPIs 66270040002015
    GCN Sequence Number 071250
    GCN Sequence Number Description golimumab VIAL 50 MG/4 ML INTRAVEN
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 34983
    HICL Sequence Number 036278
    HICL Sequence Number Description GOLIMUMAB
    Brand/Generic Brand
    Proprietary Name SIMPONI ARIA
    Proprietary Name Suffix n/a
    Non-Proprietary Name golimumab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/4mL
    Substance Name GOLIMUMAB
    Labeler Name Janssen Biotech, Inc.
    Pharmaceutical Class Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125433
    Listing Certified Through 2024-12-31

    Package

    NDC 57894-0350-89 (57894035089)

    NDC Package Code 57894-350-89
    Billing NDC 57894035089
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-350-89) / 4 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2013-07-19
    NDC Exclude Flag N
    Pricing Information N/A