CERTOLIZUMAB PEGOL - Food and Drug Administration

Set ID: f8d435c8-c279-4e44-8bbd-a2bd568deb03
Type: Indexing - product concept
Effective date: 2015-09-30
Version: 1
Source: DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
Label	Relation	Manufacturer	Effective
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	Product name	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.	2026-02-24
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	Product name	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.	2026-01-16
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	Product name	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.	2025-11-10
These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	Product name	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.	2025-07-08

NDC, DailyMed label, Manufacturer table
NDC	DailyMed label	Manufacturer
50474-700	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-700	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-700-61	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-700-61	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-700-62	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-700-62	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-710	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-710	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-710-79	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-710-79	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-710-80	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-710-80	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-710-81	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-710-81	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-750	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-750	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.
50474-750-10	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Vetter Pharma Fertigung GmbH & Co. KG \| Unither Manufacturing, LLC \| UCB Farchim S.A.
50474-750-10	These highlights do not include all the information needed to use CIMZIA® safely and effectively. See full prescribing information for CIMZIA. CIMZIA (certolizumab pegol) for injection, for subcutaneous use CIMZIA (certolizumab pegol) injection, for subcutaneous use Initial U.S. Approval: 2008	UCB, Inc. \| UCB Pharma S.A. \| Unither Manufacturing, LLC \| Vetter Pharma Fertigung GmbH & Co. KG \| UCB Farchim S.A.