ZIEXTENZO
These highlights do not include all the information needed to use ZIEXTENZO safely and effectively. See full prescribing information for ZIEXTENZO. ZIEXTENZO (pegfilgrastim-bmez) is biosimilar* to NEULASTA (pegfilgrastim).Initial U.S. Approval: 2019
Approved
Approval ID
7dada041-6528-4acf-809c-62d271538c9a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegfilgrastim-bmez
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-866
Application NumberBLA761045
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegfilgrastim-bmez
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMarch 1, 2021
FDA Product Classification
INGREDIENTS (6)
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
POLYSORBATE 20Inactive
Quantity: 0.02 mg in 0.6 mL
Code: 7T1F30V5YH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBITOLInactive
Quantity: 30 mg in 0.6 mL
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.36 mg in 0.6 mL
Code: Q40Q9N063P
Classification: IACT