Ustekinumab-aekn Injection, Solution
NDC Package 51759-413-32

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

Package Information

Ustekinumab-aekn injection is ustekinumab-aekn is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Ustekinumab-aekn [see Warnings and Precautions (5.5)]. This formulation utilizes a injection, solution delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 51759-413 and is authorized under FDA application BLA761343.

Identification & Billing

NDC Package Code
51759-413-32
Package Description
1 TRAY in 1 CARTON / 1 SYRINGE, GLASS in 1 TRAY / .5 mL in 1 SYRINGE, GLASS
Product Code
51759-413
11-Digit Billing Format
51759041332
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ustekinumab-aekn
Non-Proprietary Name
Ustekinumab-aekn
Substance Name
Ustekinumab-aekn
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)
USTEKINUMAB-AEKN 45 mg/.5mL
Pharmacologic Class
Usage Information
Ustekinumab-aekn is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in Ustekinumab-aekn [see Warnings and Precautions (5.5)].

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761343
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-23-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51759-413-32 identifies a specific commercial package of 1 tray in 1 carton / 1 syringe, glass in 1 tray / .5 ml in 1 syringe, glass of Ustekinumab-aekn, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This injection, solution is formulated for subcutaneous use and contains ustekinumab-aekn 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 Teva Pharmaceuticals Usa, Inc. on December 23, 2025. The current certification is valid through December 31, 2027.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51759041332. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
51759-413-32
11-Digit CMS (5-4-2)
51759-0413-32

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