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    NDC 78206-0186-01 Hadlima 40 mg/.4mL Details

    Hadlima 40 mg/.4mL

    Hadlima is a SUBCUTANEOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Organon LLC. The primary component is ADALIMUMAB.

    Product Information

    NDC 78206-0186
    Product ID 78206-186_943ee6ac-e3cf-4552-a468-01c9b11d7c47
    Associated GPIs
    GCN Sequence Number 084517
    GCN Sequence Number Description adalimumab-bwwd SYRINGE 40MG/0.4ML SUBCUT
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 53846
    HICL Sequence Number 045894
    HICL Sequence Number Description ADALIMUMAB-BWWD
    Brand/Generic Brand
    Proprietary Name Hadlima
    Proprietary Name Suffix n/a
    Non-Proprietary Name adalimumab-bwwd
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 40
    Active Ingredient Units mg/.4mL
    Substance Name ADALIMUMAB
    Labeler Name Organon 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 BLA761059
    Listing Certified Through 2024-12-31

    Package

    NDC 78206-0186-01 (78206018601)

    NDC Package Code 78206-186-01
    Billing NDC 78206018601
    Package 2 SYRINGE in 1 CARTON (78206-186-01) / .4 mL in 1 SYRINGE (78206-186-99)
    Marketing Start Date 2023-07-01
    NDC Exclude Flag N
    Pricing Information N/A