UDENYCA
These highlights do not include all the information needed to use UDENYCA safely and effectively. See full prescribing information for UDENYCA. UDENYCA (pegfilgrastim-cbqv) injection, for subcutaneous use INITIAL U.S. APPROVAL: 2018
Approved
Approval ID
a8c290ee-b699-4395-a596-1453d4a4b4eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Coherus BioSciences Inc
DUNS: 078502849
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pegfilgrastim-cbqv
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70114-130
Application NumberBLA761039
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegfilgrastim-cbqv
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (6)
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
ACETATE IONInactive
Code: 569DQM74SC
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUMInactive
Code: 9NEZ333N27
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
pegfilgrastim-cbqv
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70114-120
Application NumberBLA761039
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegfilgrastim-cbqv
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (6)
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
ACETATE IONInactive
Code: 569DQM74SC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUMInactive
Code: 9NEZ333N27
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
pegfilgrastim-cbqv
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70114-101
Application NumberBLA761039
Product Classification
M
Marketing Category
C73585
G
Generic Name
pegfilgrastim-cbqv
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (6)
PEGFILGRASTIMActive
Quantity: 6 mg in 0.6 mL
Code: 3A58010674
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
ACETATE IONInactive
Code: 569DQM74SC
Classification: IACT
SODIUMInactive
Code: 9NEZ333N27
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT