Search by Drug Name or NDC

    NDC 55513-0399-01 AMJEVITA 20 mg/.2mL Details

    AMJEVITA 20 mg/.2mL

    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 55513-0399
    Product ID 55513-399_c481ca56-b445-4d59-99e8-573945962923
    Associated GPIs
    GCN Sequence Number 085224
    GCN Sequence Number Description adalimumab-atto SYRINGE 20MG/0.2ML SUBCUT
    HIC3 S2J
    HIC3 Description ANTI-INFLAMMATORY TUMOR NECROSIS FACTOR INHIBITOR
    GCN 54647
    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 20
    Active Ingredient Units mg/.2mL
    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 55513-0399-01 (55513039901)

    NDC Package Code 55513-399-01
    Billing NDC 55513039901
    Package 1 SYRINGE in 1 CARTON (55513-399-01) / .2 mL in 1 SYRINGE
    Marketing Start Date 2023-08-14
    NDC Exclude Flag N
    Pricing Information N/A