NDC 61314-326

ZARXIO

Filgrastim-sndz

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 ID61314-326_0edd8790-0898-4705-ab7c-e588e81de8e6
NDC61314-326
Product TypeHuman Prescription Drug
Proprietary NameZARXIO
Generic NameFilgrastim-sndz
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2015-03-06
Marketing CategoryBLA / BLA
Application NumberBLA125553
Labeler NameSandoz Inc.
Substance NameFILGRASTIM
Active Ingredient Strength480 ug/.8mL
Pharm ClassesGranulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 61314-326-01

1 BLISTER PACK in 1 CARTON (61314-326-01) > 1 SYRINGE in 1 BLISTER PACK > .8 mL in 1 SYRINGE
Marketing Start Date2018-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61314-326-10 [61314032610]

ZARXIO INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-22

NDC 61314-326-01 [61314032601]

ZARXIO INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-22

NDC 61314-326-05 [61314032605]

ZARXIO INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125553
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-06

Drug Details

Active Ingredients

IngredientStrength
FILGRASTIM480 ug/.8mL

OpenFDA Data

SPL SET ID:c0d1c22b-566b-4776-bdbf-00f96dad0cae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1605075
  • 1605066
  • 1605074
  • 1605071
  • Pharmacological Class

    • Granulocyte Colony-Stimulating Factor [CS]
    • Granulocyte-Macrophage Colony-Stimulating Factor [CS]
    • Increased Myeloid Cell Production [PE]
    • Leukocyte Growth Factor [EPC]

    NDC Crossover Matching brand name "ZARXIO" or generic name "Filgrastim-sndz"

    NDCBrand NameGeneric Name
    61314-304ZARXIOfilgrastim-sndz
    61314-312ZARXIOfilgrastim-sndz
    61314-318ZARXIOfilgrastim-sndz
    61314-326ZARXIOfilgrastim-sndz

    Trademark Results [ZARXIO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZARXIO
    ZARXIO
    86242357 4886448 Live/Registered
    Novartis AG
    2014-04-04
    ZARXIO
    ZARXIO
    85804965 4841708 Live/Registered
    Novartis AG
    2012-12-18

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