NDC 61314-318

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 ID: 61314-318_0edd8790-0898-4705-ab7c-e588e81de8e6
• NDC: 61314-318
• 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
• 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 61314-318-01

1 BLISTER PACK in 1 CARTON (61314-318-01) > 1 SYRINGE in 1 BLISTER PACK > .5 mL in 1 SYRINGE

• Marketing Start Date: 2018-02-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61314-318-01 [61314031801]

ZARXIO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-22

NDC 61314-318-10 [61314031810]

ZARXIO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-22

NDC 61314-318-05 [61314031805]

ZARXIO INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125553
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-06

Drug Details

Active Ingredients

Ingredient	Strength
FILGRASTIM	300 ug/.5mL

OpenFDA Data

• SPL SET ID: c0d1c22b-566b-4776-bdbf-00f96dad0cae
• 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