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    NDC 61314-0326-10 ZARXIO 480 ug/.8mL Details

    ZARXIO 480 ug/.8mL

    ZARXIO is a INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc.. The primary component is FILGRASTIM.

    Product Information

    NDC 61314-0326
    Product ID 61314-326_66b6af40-d900-4391-af20-aac49feaa59d
    Associated GPIs 8240152060E540
    GCN Sequence Number 073645
    GCN Sequence Number Description filgrastim-sndz SYRINGE 480MCG/0.8 INJECTION
    HIC3 N1C
    HIC3 Description LEUKOCYTE (WBC) STIMULANTS
    GCN 38082
    HICL Sequence Number 041814
    HICL Sequence Number Description FILGRASTIM-SNDZ
    Brand/Generic Brand
    Proprietary Name ZARXIO
    Proprietary Name Suffix n/a
    Non-Proprietary Name filgrastim-sndz
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS; SUBCUTANEOUS
    Active Ingredient Strength 480
    Active Ingredient Units ug/.8mL
    Substance Name FILGRASTIM
    Labeler Name Sandoz Inc.
    Pharmaceutical Class Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125553
    Listing Certified Through 2024-12-31

    Package

    NDC 61314-0326-10 (61314032610)

    NDC Package Code 61314-326-10
    Billing NDC 61314032610
    Package 2 BLISTER PACK in 1 CARTON (61314-326-10) / 5 SYRINGE in 1 BLISTER PACK (61314-326-05) / .8 mL in 1 SYRINGE
    Marketing Start Date 2018-02-22
    NDC Exclude Flag N
    Pricing Information N/A