NDC 61314-304

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, License Holder Unspecified.

• Product ID: 61314-304_1dde2a6f-bcf7-42d6-83ef-2069f362c3b4
• NDC: 61314-304
• Product Type: Human Prescription Drug
• Proprietary Name: ZARXIO
• Generic Name: Filgrastim-sndz
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2015-03-06
• Marketing Category: BLA / BLA
• Application Number: BLA125553
• Labeler Name: Sandoz Inc
• Substance Name: FILGRASTIM, LICENSE HOLDER UNSPECIFIED
• Active Ingredient Strength: 300 ug/.5mL
• Pharm Classes: Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61314-304-01

1 BLISTER PACK in 1 CARTON (61314-304-01) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE

• Marketing Start Date: 2015-09-03
• Marketing End Date: 2021-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61314-304-01 [61314030401]

ZARXIO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-09-03

NDC 61314-304-10 [61314030410]

ZARXIO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-09-03

Drug Details

Active Ingredients

Ingredient	Strength
FILGRASTIM, LICENSE HOLDER UNSPECIFIED	300 ug/.5mL

OpenFDA Data

• SPL SET ID: fe707775-a0ae-41b5-a744-28c41889fce8
• Manufacturer:
  • Sandoz Inc
• UNII:
  • PVI5M0M1GW
• 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"

NDC	Brand Name	Generic Name
61314-304	ZARXIO	filgrastim-sndz
61314-312	ZARXIO	filgrastim-sndz
61314-318	ZARXIO	filgrastim-sndz
61314-326	ZARXIO	filgrastim-sndz