FDA.reportPublic FDA data

1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]

RxCUI
849599
RxNorm name
1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]
Display name
1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]
Full name
1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:17

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125160Cimziacertolizumab pegol351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CimziaCERTOLIZUMAB PEGOLUCB, Inc.b4c2c9dc-a0bb-4d64-a667-a67ebe88392d2026-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 849599

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
b4c2c9dc-a0bb-4d64-a667-a67ebe88392dCimzia 200 MG in 1 ML Prefilled Syringe [PSN] · 1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia] [SBD] · 1ML Cimzia 200 MG/ML Prefilled Syringe [SY] · Cimzia 200 MG per 1 ML Prefilled Syringe [SY]447These 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: 200820260224