Home NDC 50474-710 Cimzia
Product NDC 50474-710
11-digit product format 504740710
Labeler code 50474
Product ID 50474-710_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 2009-05-14
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50474-710-79 Cimzia 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 47 50474-710-79 Cimzia 2 in 1 CARTON INJECTION, SOLUTION 2 47 50474-710-80 Cimzia 1 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 1 47 50474-710-80 Cimzia 2 in 1 CARTON INJECTION, SOLUTION 2 47 50474-710-81 Cimzia 3 in 1 BOX INJECTION, SOLUTION 3 47 50474-710-81 Cimzia 2 in 1 CARTON INJECTION, SOLUTION 2 47
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 50474-710 CIMZIA (CERTOLIZUMAB PEGOL) KIT CIMZIA (CERTOLIZUMAB PEGOL) INJECTION, SOLUTION [UCB, INC.] 39 Current NDC, Legacy NDC, 6 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.
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
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 Units Marketing start Marketing end Sample Exclude flag Status 50474-710-79 50474071079 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASS 2009-05-14 0000-00-00 No No Current 50474-710-80 50474071080 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASS 2009-05-14 0000-00-00 Yes No Current 50474-710-81 50474071081 3 CARTON in 1 BOX (50474-710-81) / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS 3 carton 2009-05-14 0000-00-00 No No Current