Tremfya Injection
NDC Package 57894-640-99

11-digit billing NDC: 57894064099 · Billing unit: ML · 1 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Tremfya (guselkumab) injection is tREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1)]. This formulation utilizes a injection delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-640 and is authorized under FDA application BLA761061.

Identification & Billing

NDC Package Code
57894-640-99
Package Description
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
Product Code
57894-640
11-Digit Billing Format
57894064099
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
1 ML
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
GUSELKUMAB 100 mg/mL
Pharmacologic Class
Usage Information
TREMFYA is contraindicated in patients with a history of serious hypersensitivity reaction to guselkumab or to any of the excipients [see Warnings and Precautions (5.1)].

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
07-13-2017
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 (57894-640). Click a package code to view its specific billing and regulatory data.

57894-640-01
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
57894-640-04
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
57894-640-06
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE (57894-640-03)
57894-640-11
1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE

* 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 57894-640-99 identifies a specific commercial package of 1 syringe in 1 carton / 1 ml in 1 syringe of Tremfya, a human prescription drug labeled by Janssen Biotech, Inc.. This injection is formulated for subcutaneous 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 July 13, 2017. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894064099. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
57894-640-99
11-Digit CMS (5-4-2)
57894-0640-99

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