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    NDC 55513-0760-91 REPATHA 140 mg/mL Details

    REPATHA 140 mg/mL

    REPATHA is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is EVOLOCUMAB.

    Product Information

    NDC 55513-0760
    Product ID 55513-760_ad0cad06-6727-4812-89f4-beb4f2e92a5c
    Associated GPIs 3935002000D520
    GCN Sequence Number 074564
    GCN Sequence Number Description evolocumab PEN INJCTR 140 MG/ML SUBCUT
    HIC3 M4T
    HIC3 Description ANTIHYPERLIPIDEMIC - PCSK9 INHIBITORS
    GCN 38178
    HICL Sequence Number 042378
    HICL Sequence Number Description EVOLOCUMAB
    Brand/Generic Brand
    Proprietary Name REPATHA
    Proprietary Name Suffix n/a
    Non-Proprietary Name Evolocumab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 140
    Active Ingredient Units mg/mL
    Substance Name EVOLOCUMAB
    Labeler Name Amgen Inc
    Pharmaceutical Class Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125522
    Listing Certified Through 2024-12-31

    Package

    NDC 55513-0760-91 (55513076091)

    NDC Package Code 55513-760-91
    Billing NDC 55513076091
    Package 1 SYRINGE in 1 CARTON (55513-760-91) / 1 mL in 1 SYRINGE
    Marketing Start Date 2015-08-31
    NDC Exclude Flag N
    Pricing Information N/A