NDC 61314-866

ZIEXTENZO

Pegfilgrastim-bmez

ZIEXTENZO is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Pegfilgrastim.

• Product ID: 61314-866_0bd4f675-dfc1-45df-9b1e-b665563459d4
• NDC: 61314-866
• Product Type: Human Prescription Drug
• Proprietary Name: ZIEXTENZO
• Generic Name: Pegfilgrastim-bmez
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2019-11-04
• Marketing Category: BLA / BLA
• Application Number: BLA761045
• Labeler Name: Sandoz Inc
• Substance Name: PEGFILGRASTIM
• Active Ingredient Strength: 6 mg/.6mL
• 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: 2022-12-31

Packaging

NDC 61314-866-01

1 BLISTER PACK in 1 CARTON (61314-866-01) > 1 SYRINGE in 1 BLISTER PACK > .6 mL in 1 SYRINGE

• Marketing Start Date: 2019-11-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61314-866-01 [61314086601]

ZIEXTENZO INJECTION

• Marketing Category: BLA
• Application Number: BLA761045
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-11-04

Drug Details

Active Ingredients

Ingredient	Strength
PEGFILGRASTIM	6 mg/.6mL

Pharmacological Class

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