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    NDC 00069-0293-10 Nivestym 300 ug/mL Details

    Nivestym 300 ug/mL

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

    Product Information

    NDC 00069-0293
    Product ID 0069-0293_81738cc9-08b9-44d0-a8b0-d307ca93249e
    Associated GPIs 82401520102020
    GCN Sequence Number 078719
    GCN Sequence Number Description filgrastim-aafi VIAL 300 MCG/ML INJECTION
    HIC3 N1C
    HIC3 Description LEUKOCYTE (WBC) STIMULANTS
    GCN 45098
    HICL Sequence Number 045154
    HICL Sequence Number Description FILGRASTIM-AAFI
    Brand/Generic Brand
    Proprietary Name Nivestym
    Proprietary Name Suffix n/a
    Non-Proprietary Name filgrastim-aafi
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS; SUBCUTANEOUS
    Active Ingredient Strength 300
    Active Ingredient Units ug/mL
    Substance Name FILGRASTIM
    Labeler Name Pfizer Laboratories Div Pfizer 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 BLA761080
    Listing Certified Through 2024-12-31

    Package

    NDC 00069-0293-10 (00069029310)

    NDC Package Code 0069-0293-10
    Billing NDC 00069029310
    Package 10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0293-10) / 1 mL in 1 VIAL, SINGLE-DOSE (0069-0293-01)
    Marketing Start Date 2019-03-11
    NDC Exclude Flag N
    Pricing Information N/A