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    NDC 00944-3054-02 ADVATE Details

    ADVATE

    ADVATE is a KIT in the PLASMA DERIVATIVE category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is .

    Product Information

    NDC 00944-3054
    Product ID 0944-3054_e3808f08-3c70-4d96-81a9-519f9d384951
    Associated GPIs 85100010252150
    GCN Sequence Number 063070
    GCN Sequence Number Description antihemophil.FVIII,full length VIAL 1500 (+/-) INTRAVEN
    HIC3 M0E
    HIC3 Description ANTIHEMOPHILIC FACTORS
    GCN 98830
    HICL Sequence Number 041651
    HICL Sequence Number Description ANTIHEMOPHILIC FACTOR (FVIII) RECOMBINANT,FULL LENGTH
    Brand/Generic Brand
    Proprietary Name ADVATE
    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 Takeda Pharmaceuticals America, Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125063
    Listing Certified Through 2024-12-31

    Package

    NDC 00944-3054-02 (00944305402)

    NDC Package Code 0944-3054-02
    Billing NDC 00944305402
    Package 1 BLISTER PACK in 1 CARTON (0944-3054-02) / 1 CONTAINER in 1 BLISTER PACK (0944-3054-03) / 1 KIT in 1 CONTAINER (0944-3054-04) * 5 mL in 1 VIAL, GLASS (0944-2944-02) * 2 mL in 1 VIAL, GLASS (64764-514-02)
    Marketing Start Date 2011-12-15
    NDC Exclude Flag N
    Pricing Information N/A