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    NDC 63459-0910-11 GRANIX 300 ug/.5mL Details

    GRANIX 300 ug/.5mL

    GRANIX is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cephalon, LLC. The primary component is FILGRASTIM.

    Product Information

    NDC 63459-0910
    Product ID 63459-910_6c844d2a-1b12-4434-a915-dad9ad4b094f
    Associated GPIs 8240152070E530
    GCN Sequence Number 071653
    GCN Sequence Number Description tbo-filgrastim SYRINGE 300MCG/0.5 SUBCUT
    HIC3 N1C
    HIC3 Description LEUKOCYTE (WBC) STIMULANTS
    GCN 35575
    HICL Sequence Number 040426
    HICL Sequence Number Description TBO-FILGRASTIM
    Brand/Generic Brand
    Proprietary Name GRANIX
    Proprietary Name Suffix n/a
    Non-Proprietary Name tbo-filgrastim
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route SUBCUTANEOUS
    Active Ingredient Strength 300
    Active Ingredient Units ug/.5mL
    Substance Name FILGRASTIM
    Labeler Name Cephalon, LLC
    Pharmaceutical Class Granulocyte Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC]
    DEA Schedule n/a
    Marketing Category BLA
    Application Number BLA125294
    Listing Certified Through 2024-12-31

    Package

    NDC 63459-0910-11 (63459091011)

    NDC Package Code 63459-910-11
    Billing NDC 63459091011
    Package 1 BLISTER PACK in 1 CARTON (63459-910-11) / 1 SYRINGE, GLASS in 1 BLISTER PACK (63459-910-12) / .5 mL in 1 SYRINGE, GLASS (63459-910-01)
    Marketing Start Date 2013-11-11
    NDC Exclude Flag N
    Pricing Information N/A