Cimzia Injection, Solution
NDC 50474-710

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50474-710?
  5. Cimzia Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Cimzia (certolizumab pegol) is a BLA-approved product labeled by Ucb, Inc.. This medication is used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis). It is supplied as a white injection, solution for subcutaneous administration. This product entry covers the primary NDC 50474-710 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50474-710
Proprietary Name:
Cimzia
Non-Proprietary Name: [1]
Certolizumab Pegol
Substance Name: [2]
Certolizumab Pegol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Labeler & Regulatory Data

Labeler Name: [5]
Ucb, Inc.
Labeler Code:
50474
Product Label ID:
b4c2c9dc-a0bb-4d64-a667-a67ebe88392d
FDA Application Number: [6]
BLA125160
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
05-14-2009
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
YELLOW (C48330 - COLORLESS TO PALE YELLOW)

Code Structure Chart

Product Details

What is NDC 50474-710?

The NDC code 50474-710 is assigned by the FDA to the product Cimzia. It is commonly known by its generic name, certolizumab pegol. This pharmaceutical product is labeled by Ucb, Inc. and is currently categorized as listed product. The medication is a injection, solution administered via subcutaneous route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 50474-710-79, 50474-710-80, 50474-710-81. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis). Some brands may also be used to treat a certain type of spine condition (axial spondyloarthritis) or a certain bowel condition (Crohn's disease). Certolizumab belongs to a class of drugs known as tumor necrosis factor (TNF) blockers. It works by blocking TNF, a substance made by the body that causes inflammation.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CERTOLIZUMAB PEGOL 200 mg/mL - A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 2724369 - {2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe) } Pack
  • RxCUI: 2724369 - certolizumab pegol 200 MG in 1 ML Prefilled Syringe, 2 count
  • RxCUI: 2724369 - certolizumab pegol 200 MG per 1 ML Prefilled Syringe, 2 count
  • RxCUI: 2724370 - {2 (1 ML certolizumab pegol 200 MG/ML Prefilled Syringe [Cimzia]) } Pack [Cimzia (2 count)]
  • RxCUI: 2724370 - Cimzia Prefilled Syringe, 2 count

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Certolizumab Injection


Certolizumab injection is used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following: Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications, rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function), psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin), active ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain, swelling, and joint damage) with changes seen on X-ray, active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas causing pain and signs of swelling), but without changes seen on X-ray, plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in people who may benefit from medications or phototherapy (a treatment that involves exposing the skin to ultraviolet light). Certolizumab injection is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the activity of TNF, a substance in the body that causes inflammation.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".