Tremfya Injection
NDC Package 57894-640-99
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 57894-640 and is authorized under FDA application BLA761061.
Identification & Billing
- RxCUI: 1928686 - guselkumab 100 MG in 1 ML Prefilled Syringe
- RxCUI: 1928686 - 1 ML guselkumab 100 MG/ML Prefilled Syringe
- RxCUI: 1928689 - Tremfya 100 MG in 1 ML Prefilled Syringe
- RxCUI: 1928689 - 1 ML guselkumab 100 MG/ML Prefilled Syringe [Tremfya]
- RxCUI: 1928689 - 1 ML Tremfya 100 MG/ML Prefilled Syringe
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 57894 - Janssen Biotech, Inc.
- 57894-640 - Tremfya
- 57894-640-99 - 1 SYRINGE in 1 CARTON / 1 mL in 1 SYRINGE
- 57894-640 - Tremfya
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.
* 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.
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: 57894064099. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
