FDA.reportPublic FDA data

Cimzia

Product NDC
50474-700
11-digit product format
504740700
Labeler code
50474
Product ID
50474-700_4b984e6f-72ac-4fdc-e063-6394a90af105
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

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUMD07X179E
Rxcui795081, 795085, 849597, 849599, 2724369, 2724370, 2724371, 2724372

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

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
50474-700-62504740700622 KIT in 1 CARTON (50474-700-62) / 1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS2 kit2008-04-200000-00-00NoNoCurrent