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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50474-710
Application NumberBLA125160
Product Classification
M
Marketing Category
C73585
G
Generic Name
certolizumab pegol
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 3, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50474-700
Application NumberBLA125160
Product Classification
M
Marketing Category
C73585
G
Generic Name
certolizumab pegol
Product Specifications
Effective DateJanuary 3, 2023
FDA Product Classification