Cimzia Injection, Solution
NDC Package 50474-710-79

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Cimzia (certolizumab pegol) injection is a medication used to reduce pain and swelling due to certain inflammatory conditions (such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis). This formulation utilizes a injection, solution delivery system. Marketed by Ucb, Inc., this product is identified by NDC 50474-710 and is authorized under FDA application BLA125160.

Identification & Billing

NDC Package Code
50474-710-79
Package Description
2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code
50474-710
11-Digit Billing Format
50474071079
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Cimzia
Non-Proprietary Name
Certolizumab Pegol
Substance Name
Certolizumab Pegol
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
CERTOLIZUMAB PEGOL 200 mg/mL
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Ucb, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125160
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-14-2009
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50474-710). Click a package code to view its specific billing and regulatory data.

50474-710-80
2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
50474-710-81
3 CARTON in 1 BOX / 2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50474-710-79 identifies a specific commercial package of 2 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Cimzia, a human prescription drug labeled by Ucb, Inc.. This injection, solution is formulated for subcutaneous use and contains certolizumab pegol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Ucb, Inc. on May 14, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Ucb, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50474071079. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50474-710-79
11-Digit CMS (5-4-2)
50474-0710-79

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.