Ustekinumab Injection, Solution
NDC Package 57894-441-01

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

Package Information

Ustekinumab injection is ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). This formulation utilizes a injection, solution delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-441 and is authorized under FDA application BLA125261.

Identification & Billing

NDC Package Code
57894-441-01
Package Description
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
57894-441
11-Digit Billing Format
57894044101
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
Non-Proprietary Name
Ustekinumab
Substance Name
Ustekinumab
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 90 mg/mL
Pharmacologic Class
Usage Information
Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125261
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-01-2025
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 57894-441-01 identifies a specific commercial package of 1 syringe in 1 carton / 1 ml in 1 syringe of Ustekinumab, a human prescription drug labeled by Janssen Biotech, Inc.. This injection, solution is formulated for subcutaneous use and contains ustekinumab 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 Janssen Biotech, Inc. on April 01, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894044101. 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)
57894-441-01
11-Digit CMS (5-4-2)
57894-0441-01

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