Cimzia

Product NDC: 50474-750
11-digit product format: 504740750
Labeler code: 50474
Product ID: 50474-750_4b984e6f-72ac-4fdc-e063-6394a90af105
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: certolizumab pegol
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: UCB, Inc.
Application: BLA125160
Marketing category: BLA
Marketing start: 2025-03-01
Substance: CERTOLIZUMAB PEGOL
Active strength: 200 mg/mL
Pharmacologic classes: Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CERTOLIZUMAB PEGOL	200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UMD07X179E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f8d435c8-c279-4e44-8bbd-a2bd568deb03	Product name	1	20150930
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50474-750-10	Cimzia	1 in 1 CARTON	INJECTION, SOLUTION	1		47
50474-750-10	Cimzia	1 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	1		47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50474-750-10	EA - Each	50474-750	66d45e90-6f0f-429f-9f26-4770375cad76	1	2025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
certolizumab pegol	ACTIVE INGREDIENT	UMD07X179E	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18
certolizumab pegol	ACTIVE MOIETY	UMD07X179E	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18
sodium acetate	INACTIVE INGREDIENT	4550K0SC9B	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18
sucrose	INACTIVE INGREDIENT	C151H8M554	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18
Water	INACTIVE INGREDIENT	059QF0KO0R	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50474-750	CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.]	39	Current NDC, 2 package rows	20250302_b4c2c9dc-a0bb-4d64-a667-a67ebe88392d.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cimzia	CERTOLIZUMAB PEGOL	UCB, Inc.	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125160 ndc (product): 50474-750

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125160	Cimzia	certolizumab pegol	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UMD07X179E	CERTOLIZUMAB PEGOL	428863-50-7	CERTOLIZUMAB PEGOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2724370	{2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia (2 count)]	BPCK	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724372	{6 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia Starter Kit (6 count)]	BPCK	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724369	{2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } Pack	GPCK	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724371	{6 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } Pack	GPCK	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849597	certolizumab pegol 200 MG in 1 ML Prefilled Syringe	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724369	certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 2 count	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724371	certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 6 count	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
795081	certolizumab pegol 200 MG Injection	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849599	Cimzia 200 MG in 1 ML Prefilled Syringe	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
795085	Cimzia 200 MG Injection	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724370	Cimzia Prefilled Syringe, 2 count	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724372	Cimzia Starter Kit, 6 count	PSN	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849599	1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]	SBD	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
795085	certolizumab pegol 200 MG Injection [Cimzia]	SBD	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849597	1 ML certolizumab pegol 200 MG/ML Prefilled Syringe	SCD	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
795081	certolizumab pegol 200 MG Injection	SCD	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849599	1ML Cimzia 200 MG/ML Prefilled Syringe	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849597	certolizumab pegol 200 MG per 1 ML Prefilled Syringe	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724369	certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 2 count	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724371	certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 6 count	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
795085	Cimzia 200 MG Injection	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
849599	Cimzia 200 MG per 1 ML Prefilled Syringe	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724370	Cimzia Prefilled Syringe, 2 count	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47
2724372	Cimzia Starter Kit, 6 count	SY	b4c2c9dc-a0bb-4d64-a667-a67ebe88392d	47

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50474-750-10	50474075010	1 SYRINGE, GLASS in 1 CARTON (50474-750-10) / 1 mL in 1 SYRINGE, GLASS	2025-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cimzia	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	47