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    NDC 00026-3828-99 Kovaltry Details

    Kovaltry

    Kovaltry is a KIT in the PLASMA DERIVATIVE category. It is labeled and distributed by Bayer HealthCare LLC. The primary component is .

    Product Information

    NDC 00026-3828
    Product ID 0026-3828_8d9498f7-77e5-4bf8-b68a-69464ada2790
    Associated GPIs 85100010252180
    GCN Sequence Number 062863
    GCN Sequence Number Description antihemophil.FVIII,full length VIAL 3000 (+/-) INTRAVEN
    HIC3 M0E
    HIC3 Description ANTIHEMOPHILIC FACTORS
    GCN 98634
    HICL Sequence Number 041651
    HICL Sequence Number Description ANTIHEMOPHILIC FACTOR (FVIII) RECOMBINANT,FULL LENGTH
    Brand/Generic Brand
    Proprietary Name Kovaltry
    Proprietary Name Suffix n/a
    Non-Proprietary Name Antihemophilic Factor (Recombinant)
    Product Type PLASMA DERIVATIVE
    Dosage Form KIT
    Route n/a
    Active Ingredient Strength n/a
    Active Ingredient Units n/a
    Substance Name n/a
    Labeler Name Bayer HealthCare LLC
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125574
    Listing Certified Through 2024-12-31

    Package

    NDC 00026-3828-99 (00026382899)

    NDC Package Code 0026-3828-99
    Billing NDC 00026382899
    Package 1 KIT in 1 BOX (0026-3828-99) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-99) * 5 mL in 1 SYRINGE (0026-0426-05) * 5 mL in 1 VIAL, SINGLE-USE (0026-4828-01)
    Marketing Start Date 2016-03-17
    NDC Exclude Flag N
    Pricing Information N/A