Bimzelx Injection, Solution
NDC Package 50474-780-79

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

Bimzelx (bimekizumab) injection is bIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. This formulation utilizes a injection, solution delivery system. Marketed by Ucb, Inc., this product is identified by NDC 50474-780 and is authorized under FDA application BLA761151.

Identification & Billing

NDC Package Code
50474-780-79
Package Description
2 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS
Product Code
50474-780
11-Digit Billing Format
50474078079
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bimzelx
Non-Proprietary Name
Bimekizumab
Substance Name
Bimekizumab
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)
BIMEKIZUMAB 160 mg/mL
Usage Information
BIMZELX is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Regulatory & Marketing

Labeler Name
Ucb, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761151
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-17-2023
Listing Expiration
12-31-2026
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 (50474-780). Click a package code to view its specific billing and regulatory data.

50474-780-78
1 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 50474-780-79 identifies a specific commercial package of 2 syringe, glass in 1 carton / 1 ml in 1 syringe, glass of Bimzelx, a human prescription drug labeled by Ucb, Inc.. This injection, solution is formulated for subcutaneous use and contains bimekizumab 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 October 17, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50474078079. 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)
50474-780-79
11-Digit CMS (5-4-2)
50474-0780-79

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