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    NDC 44206-0455-10 Hizentra 0.2 g/mL Details

    Hizentra 0.2 g/mL

    Hizentra is a SUBCUTANEOUS LIQUID in the PLASMA DERIVATIVE category. It is labeled and distributed by CSL Behring AG. The primary component is HUMAN IMMUNOGLOBULIN G.

    Product Information

    NDC 44206-0455
    Product ID 44206-455_411c01a7-0ae7-45d2-8b4c-cbe99a2ba264
    Associated GPIs 19100020202065
    GCN Sequence Number 071487
    GCN Sequence Number Description immun glob G(IgG)/pro/IgA 0-50 VIAL 10 G/50 ML SUBCUT
    HIC3 W7K
    HIC3 Description ANTISERA
    GCN 35316
    HICL Sequence Number 041798
    HICL Sequence Number Description IMMUNE GLOBULIN,GAMMA (IGG)/PROLINE/IGA 0 TO 50 MCG/ML
    Brand/Generic Brand
    Proprietary Name Hizentra
    Proprietary Name Suffix n/a
    Non-Proprietary Name HUMAN IMMUNOGLOBULIN G
    Product Type PLASMA DERIVATIVE
    Dosage Form LIQUID
    Route SUBCUTANEOUS
    Active Ingredient Strength 0.2
    Active Ingredient Units g/mL
    Substance Name HUMAN IMMUNOGLOBULIN G
    Labeler Name CSL Behring AG
    Pharmaceutical Class Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125350
    Listing Certified Through 2024-12-31

    Package

    NDC 44206-0455-10 (44206045510)

    NDC Package Code 44206-455-10
    Billing NDC 44206045510
    Package 1 VIAL, SINGLE-DOSE in 1 CARTON (44206-455-10) / 50 mL in 1 VIAL, SINGLE-DOSE (44206-455-93)
    Marketing Start Date 2011-10-03
    NDC Exclude Flag N
    Pricing Information N/A