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    NDC 58406-0435-04 ENBREL 50 mg/mL Details

    ENBREL 50 mg/mL

    ENBREL is a SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Immunex Corporation. The primary component is ETANERCEPT.

    Product Information

    NDC 58406-0435
    Product ID 58406-435_29187b7c-d166-45e4-bc8c-4cbf71a67702
    Associated GPIs 6629003000E530
    GCN Sequence Number 058214
    GCN Sequence Number Description etanercept SYRINGE 50MG/ML(1) SUBCUT
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 23574
    HICL Sequence Number 018830
    HICL Sequence Number Description ETANERCEPT
    Brand/Generic Brand
    Proprietary Name ENBREL
    Proprietary Name Suffix n/a
    Non-Proprietary Name etanercept
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name ETANERCEPT
    Labeler Name Immunex Corporation
    Pharmaceutical Class Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA103795
    Listing Certified Through 2024-12-31

    Package

    NDC 58406-0435-04 (58406043504)

    NDC Package Code 58406-435-04
    Billing NDC 58406043504
    Package 4 SYRINGE in 1 CARTON (58406-435-04) / 1 mL in 1 SYRINGE (58406-435-01)
    Marketing Start Date 2005-10-06
    NDC Exclude Flag N
    Pricing Information N/A