Cimzia
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008
Approved
Approval ID
b4c2c9dc-a0bb-4d64-a667-a67ebe88392d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2023
Manufacturers
FDA
UCB, Inc.
DUNS: 028526403
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
certolizumab pegol
PRODUCT DETAILS
NDC Product Code50474-710
Application NumberBLA125160
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 3, 2023
Generic Namecertolizumab pegol
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Quantity: 7.31 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM ACETATEInactive
Quantity: 1.36 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CERTOLIZUMAB PEGOLActive
Quantity: 200 mg in 1 mL
Code: UMD07X179E
Classification: ACTIB
certolizumab pegol
PRODUCT DETAILS
NDC Product Code50474-700
Application NumberBLA125160
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateJanuary 3, 2023
Generic Namecertolizumab pegol