OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Cimzia

certolizumab pegol · Injection, Solution

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Cimzia
Generic name
certolizumab pegol
Dosage form
Injection, Solution
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
UCB, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
4
Data completeness
52% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Certolizumab Pegol 200 mg/mL 795081 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection, Solution
Route of administration
Subcutaneous
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Tumor Necrosis Factor Blocker [EPC] EPC All 10 members
Tumor Necrosis Factor Receptor Blocking Activity [MoA] MoA All 10 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
125160
Application type
BLA · Biologics License Application
Approval date
April 22, 2008
Sponsor
UCB INC
Products on application
1
Submissions recorded
35
Products approved under application 125160.
Product Trade name Form Strength Ingredient Status TE Flags
125160-001 CIMZIA INJECTABLE CERTOLIZUMAB PEGOL Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 125160.
Type No. Action Status Date Review
Supplement 315 Labeling Approved September 23, 2025 Standard
Supplement 275 Efficacy Approved September 13, 2024 Standard
Supplement 309 Labeling Approved November 8, 2023 Standard
Supplement 305 Efficacy Approved December 22, 2022 Standard
Supplement 293 Labeling Approved September 6, 2019 Standard
Supplement 237 Efficacy Approved March 28, 2019 Standard
Supplement 289 Labeling Approved February 27, 2019 Standard
Supplement 279 Manufacturing (CMC) Approved June 14, 2018 N/A
Supplement 283 Efficacy Approved May 24, 2018 Standard
Supplement 281 Labeling Approved March 20, 2018 Standard
Supplement 286 Manufacturing (CMC) Approved March 16, 2018 N/A
Supplement 270 Labeling Approved January 4, 2017 Standard
Supplement 241 Labeling Approved April 28, 2016 Standard
Supplement 266 Labeling Approved February 26, 2016 Standard
Supplement 268 Labeling Approved February 3, 2016 Standard
Supplement 264 Labeling Approved October 19, 2015 Standard
Supplement 215 Efficacy Approved October 17, 2013 Standard
Supplement 213 Efficacy Approved September 27, 2013 Standard
Supplement 189 Labeling Approved November 15, 2012 Standard
Supplement 192 Labeling Approved October 5, 2012 Standard
Supplement 186 Labeling Approved October 5, 2012 Standard
Supplement 180 Labeling Approved August 29, 2012 Standard
Supplement 142 Labeling Approved August 2, 2012 Standard
Supplement 174 Efficacy Approved April 17, 2012 Standard
Supplement 152 Labeling Approved September 14, 2011 Standard
Supplement 157 Labeling Approved September 7, 2011 Standard
Supplement 155 Labeling Approved July 26, 2011 Standard
Supplement 122 Labeling Approved December 21, 2010 Standard
Supplement 126 Labeling Approved October 6, 2010 Standard
Supplement 111 Labeling Approved July 29, 2010 Standard
Supplement 92 Labeling Approved November 18, 2009 Standard
Supplement 80 Efficacy Approved May 13, 2009 Standard
Supplement 38 Labeling Approved December 31, 2008 Standard
Supplement 36 Labeling Approved December 22, 2008 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 22, 2008 Standard

Review documents

  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 25, 2025
  • 0 · Supplement · September 24, 2025
  • 0 · Supplement · September 16, 2024
  • 0 · Supplement · September 16, 2024
  • 0 · Supplement · November 14, 2023
  • 0 · Supplement · May 10, 2023
  • 0 · Supplement · December 27, 2022
  • 0 · Supplement · December 23, 2022
  • 0 · Supplement · January 7, 2021
  • 0 · Supplement · October 31, 2019
  • 0 · Supplement · September 9, 2019
  • 0 · Supplement · September 9, 2019
  • 0 · Supplement · June 3, 2019
  • 0 · Supplement · April 2, 2019
  • 0 · Supplement · March 29, 2019
  • 0 · Supplement · February 28, 2019
  • 0 · Supplement · February 28, 2019
  • 0 · Supplement · May 29, 2018
  • 0 · Supplement · May 29, 2018
  • 0 · Supplement · March 28, 2018
  • 0 · Supplement · March 28, 2018
  • 0 · Supplement · January 5, 2017
  • 0 · Supplement · January 5, 2017
  • 0 · Supplement · May 4, 2016
  • 0 · Supplement · April 29, 2016
  • 0 · Supplement · February 11, 2016
  • 0 · Supplement · February 4, 2016
  • 0 · Supplement · October 22, 2015
  • 0 · Supplement · October 21, 2015

Adverse event reports

Source: openFDA FAERS
116,513
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: CERTOLIZUMAB PEGOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50474-710-79 50474-710 UCB, Inc. 2 SYRINGE, GLASS in 1 CARTON (50474-710-79) / 1 mL in 1 SYRINGE, GLASS May 14, 2009
50474-710-80 50474-710 UCB, Inc. 2 SYRINGE, GLASS in 1 CARTON (50474-710-80) / 1 mL in 1 SYRINGE, GLASS May 14, 2009
50474-710-81 50474-710 UCB, Inc. 3 CARTON in 1 BOX (50474-710-81) / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS May 14, 2009
50474-750-10 50474-750 UCB, Inc. 1 SYRINGE, GLASS in 1 CARTON (50474-750-10) / 1 mL in 1 SYRINGE, GLASS March 1, 2025
50474-710 50474-710 UCB, Inc. — May 14, 2009
50474-750 50474-750 UCB, Inc. — March 1, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 9 sections on this page.