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    NDC 55513-0400-01 AMJEVITA 40 mg/.8mL Details

    AMJEVITA 40 mg/.8mL

    AMJEVITA is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is ADALIMUMAB.

    Product Information

    NDC 55513-0400
    Product ID 55513-400_c481ca56-b445-4d59-99e8-573945962923
    Associated GPIs
    GCN Sequence Number 076836
    GCN Sequence Number Description adalimumab-atto AUTO INJCT 40MG/0.8ML SUBCUT
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 42639
    HICL Sequence Number 043886
    HICL Sequence Number Description ADALIMUMAB-ATTO
    Brand/Generic Brand
    Proprietary Name AMJEVITA
    Proprietary Name Suffix n/a
    Non-Proprietary Name adalimumab-atto
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 40
    Active Ingredient Units mg/.8mL
    Substance Name ADALIMUMAB
    Labeler Name Amgen Inc
    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 BLA761024
    Listing Certified Through 2024-12-31

    Package

    NDC 55513-0400-01 (55513040001)

    NDC Package Code 55513-400-01
    Billing NDC 55513040001
    Package 1 SYRINGE in 1 CARTON (55513-400-01) / .8 mL in 1 SYRINGE
    Marketing Start Date 2023-01-31
    NDC Exclude Flag N
    Pricing Information N/A