Simponi Injection, Solution
NDC Package 57894-070-01
Package Information
Simponi (golimumab) injection is a medication used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). This formulation utilizes a injection, solution delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-070 and is authorized under FDA application BLA125289.
Identification & Billing
- RxCUI: 1482813 - golimumab 100 MG in 1 ML Prefilled Syringe
- RxCUI: 1482813 - 1 ML golimumab 100 MG/ML Prefilled Syringe
- RxCUI: 1482813 - golimumab 100 MG per 1 ML Prefilled Syringe
- RxCUI: 1482814 - Simponi 100 MG in 1 mL Prefilled Syringe
- RxCUI: 1482814 - 1 ML golimumab 100 MG/ML Prefilled Syringe [Simponi]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 57894 - Janssen Biotech, Inc.
- 57894-070 - Simponi
- 57894-070-01 - 1 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS
- 57894-070 - Simponi
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 (57894-070). 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 57894-070-01 identifies a specific commercial package of 1 syringe, glass in 1 carton / .5 ml in 1 syringe, glass of Simponi, a human prescription drug labeled by Janssen Biotech, Inc.. This injection, solution is formulated for subcutaneous use and contains golimumab 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 25, 2009. The current certification is valid through December 31, 2027.
What are the primary indications for this medication?
This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage. By reducing joint swelling, the medication helps to reduce further joint damage and preserve joint function. Depending on the type of arthritis that is being treated, this drug may be used alone or in combination with another drug called methotrexate. This medication is also used to treat a certain bowel condition (ulcerative colitis). It is used to help lessen symptoms of moderate to severe ulcerative colitis (such as abdominal pain/cramping, diarrhea, bloody stools).
How is this Janssen Biotech, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894007001. 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.
