Tremfya Injection
NDC Package 57894-650-02

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

Package Information

Tremfya (guselkumab) injection is a medication used to treat plaque psoriasis and psoriatic arthritis. This formulation utilizes a injection delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-650 and is authorized under FDA application BLA761061.

Identification & Billing

NDC Package Code
57894-650-02
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (57894-650-01)
Product Code
57894-650
11-Digit Billing Format
57894065002
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tremfya
Non-Proprietary Name
Guselkumab
Substance Name
Guselkumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GUSELKUMAB 200 mg/20mL
Pharmacologic Class
Usage Information
This medication is used to treat plaque psoriasis and psoriatic arthritis. Guselkumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural substance in your body (interleukin-23) that may cause inflammation and swelling. Guselkumab can help lessen the red, scaly, itchy patches of skin caused by plaque psoriasis and lessen the pain and swelling in the joints caused by psoriatic arthritis.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761061
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-11-2024
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 57894-650-02 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (57894-650-01) of Tremfya, a human prescription drug labeled by Janssen Biotech, Inc.. This injection is formulated for intravenous use and contains guselkumab 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 September 11, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat plaque psoriasis and psoriatic arthritis. Guselkumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural substance in your body (interleukin-23) that may cause inflammation and swelling. Guselkumab can help lessen the red, scaly, itchy patches of skin caused by plaque psoriasis and lessen the pain and swelling in the joints caused by psoriatic arthritis.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894065002. 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)
57894-650-02
11-Digit CMS (5-4-2)
57894-0650-02

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