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    NDC 65219-0554-28 Idacio 40 mg/.8mL Details

    Idacio 40 mg/.8mL

    Idacio is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ADALIMUMAB.

    Product Information

    NDC 65219-0554
    Product ID 65219-554_b2bd7097-fca7-473f-a7a4-a216eff496f2
    Associated GPIs
    GCN Sequence Number 084193
    GCN Sequence Number Description adalimumab-aacf PEN IJ KIT 40MG/0.8ML SUBCUT
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 53387
    HICL Sequence Number 048528
    HICL Sequence Number Description ADALIMUMAB-AACF
    Brand/Generic Brand
    Proprietary Name Idacio
    Proprietary Name Suffix n/a
    Non-Proprietary Name adalimumab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 40
    Active Ingredient Units mg/.8mL
    Substance Name ADALIMUMAB
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA761255
    Listing Certified Through 2024-12-31

    Package

    NDC 65219-0554-28 (65219055428)

    NDC Package Code 65219-554-28
    Billing NDC 65219055428
    Package 4 SYRINGE, GLASS in 1 CARTON (65219-554-28) / .8 mL in 1 SYRINGE, GLASS
    Marketing Start Date 2023-07-01
    NDC Exclude Flag N
    Pricing Information N/A