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    NDC 62856-0215-01 LEQEMBI 100 mg/mL Details

    LEQEMBI 100 mg/mL

    LEQEMBI is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eisai Inc.. The primary component is LECANEMAB.

    Product Information

    NDC 62856-0215
    Product ID 62856-215_f440b027-4ced-429a-970a-4ab7600c617d
    Associated GPIs
    GCN Sequence Number 084287
    GCN Sequence Number Description lecanemab-irmb VIAL 500 MG/5ML INTRAVEN
    HIC3 H1H
    HIC3 Description AMYLOID DIRECTED MONOCLONAL ANTIBODY
    GCN 53524
    HICL Sequence Number 048590
    HICL Sequence Number Description LECANEMAB-IRMB
    Brand/Generic Brand
    Proprietary Name LEQEMBI
    Proprietary Name Suffix n/a
    Non-Proprietary Name lecanemab
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 100
    Active Ingredient Units mg/mL
    Substance Name LECANEMAB
    Labeler Name Eisai Inc.
    Pharmaceutical Class Amyloid Beta-directed Antibody Interactions [MoA], Amyloid Beta-directed Antibody [EPC]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA761269
    Listing Certified Through 2024-12-31

    Package

    NDC 62856-0215-01 (62856021501)

    NDC Package Code 62856-215-01
    Billing NDC 62856021501
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (62856-215-01) / 5 mL in 1 VIAL, SINGLE-DOSE
    Marketing Start Date 2023-01-06
    NDC Exclude Flag N
    Pricing Information N/A