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    NDC 57894-0071-90 Simponi 100 mg/mL Details

    Simponi 100 mg/mL

    Simponi is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Janssen Biotech, Inc.. The primary component is GOLIMUMAB.

    Product Information

    NDC 57894-0071
    Product ID 57894-071_0aad0e31-d37e-4a67-e063-6294a90ac9b0
    Associated GPIs 6627004000E540 6627004000D540
    GCN Sequence Number 071017
    GCN Sequence Number Description golimumab SYRINGE 100 MG/ML SUBCUT
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 34697
    HICL Sequence Number 036278
    HICL Sequence Number Description GOLIMUMAB
    Brand/Generic Brand
    Proprietary Name Simponi
    Proprietary Name Suffix n/a
    Non-Proprietary Name golimumab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 100
    Active Ingredient Units mg/mL
    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 BLA125289
    Listing Certified Through 2024-12-31

    Package

    NDC 57894-0071-90 (57894007190)

    NDC Package Code 57894-071-90
    Billing NDC 57894007190
    Package 1 SYRINGE, GLASS in 1 CARTON (57894-071-90) / 1 mL in 1 SYRINGE, GLASS
    Marketing Start Date 2013-05-15
    NDC Exclude Flag N
    Pricing Information N/A