FDA.reportPublic FDA data

Cimzia

Product NDC
50474-700
Requested package NDC
50474-700-61
11-digit product format
504740700
Labeler code
50474
Product ID
50474-700_5eff2527-2590-b127-e063-6294a90afb5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
certolizumab pegol
Dosage form
KIT
Labeler
UCB, Inc.
Application
BLA125160
Marketing category
BLA
Marketing start
2008-04-20
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Cimzia
Listing expiration
2027-12-31

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UMD07X179EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
795081Internal RxNorm lookup
795085Internal RxNorm lookup
849597Internal RxNorm lookup
849599Internal RxNorm lookup
2724369Internal RxNorm lookup
2724370Internal RxNorm lookup
2724371Internal RxNorm lookup
2724372Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4c2c9dc-a0bb-4d64-a667-a67ebe88392dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f8d435c8-c279-4e44-8bbd-a2bd568deb03Product name120150930
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-700-61Cimzia2 in 1 CARTONKIT247
50474-700-61Cimzia1 in 1 KITKIT147
50474-700-62Cimzia2 in 1 CARTONKIT247
50474-700-62Cimzia1 in 1 KITKIT147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50474-700-62EA - Each50474-7000da37a75-f184-4d73-ab58-5a97c522577c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
certolizumab pegolACTIVE INGREDIENTUMD07X179ECIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18
certolizumab pegolACTIVE MOIETYUMD07X179ECIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18
lactic acidINACTIVE INGREDIENT33X04XA5ATCIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18
sodium acetateINACTIVE INGREDIENT4550K0SC9BCIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18
sodium chlorideINACTIVE INGREDIENT451W47IQ8XCIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18
sucroseINACTIVE INGREDIENTC151H8M554CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18
WaterINACTIVE INGREDIENT059QF0KO0RCIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-700CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]39Current NDC, Legacy NDC, 4 package rows20250302_b4c2c9dc-a0bb-4d64-a667-a67ebe88392d.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125160Cimziacertolizumab pegol351(a)Rx2026-10-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724370{2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia (2 count)]BPCKb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724372{6 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia Starter Kit (6 count)]BPCKb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724369{2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } PackGPCKb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724371{6 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } PackGPCKb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
849597certolizumab pegol 200 MG in 1 ML Prefilled SyringePSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724369certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 2 countPSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724371certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 6 countPSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
795081certolizumab pegol 200 MG InjectionPSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
849599Cimzia 200 MG in 1 ML Prefilled SyringePSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
795085Cimzia 200 MG InjectionPSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724370Cimzia Prefilled Syringe, 2 countPSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724372Cimzia Starter Kit, 6 countPSNb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
8495991 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]SBDb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
795085certolizumab pegol 200 MG Injection [Cimzia]SBDb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
8495971 ML certolizumab pegol 200 MG/ML Prefilled SyringeSCDb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
795081certolizumab pegol 200 MG InjectionSCDb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
8495991ML Cimzia 200 MG/ML Prefilled SyringeSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
849597certolizumab pegol 200 MG per 1 ML Prefilled SyringeSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724369certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 2 countSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724371certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 6 countSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
795085Cimzia 200 MG InjectionSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
849599Cimzia 200 MG per 1 ML Prefilled SyringeSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724370Cimzia Prefilled Syringe, 2 countSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47
2724372Cimzia Starter Kit, 6 countSYb4c2c9dc-a0bb-4d64-a667-a67ebe88392d47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50474-700-61504740700612 KIT in 1 CARTON (50474-700-61) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS2 kit2008-04-200000-00-00YesNoCurrent