Simponi Aria Solution
NDC Package 57894-350-01

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

Package Information

Simponi Aria (golimumab) solution is a medication used to treat certain types of arthritis (such as rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis). This formulation utilizes a solution delivery system. Marketed by Janssen Biotech, Inc., this product is identified by NDC 57894-350 and is authorized under FDA application BLA125433.

Identification & Billing

NDC Package Code
57894-350-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE
Product Code
57894-350
11-Digit Billing Format
57894035001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Simponi Aria
Non-Proprietary Name
Golimumab
Substance Name
Golimumab
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
GOLIMUMAB 50 mg/4mL
Pharmacologic Class
Usage Information
This medication is used to treat certain types of arthritis (such as rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis). Golimumab belongs to a class of drugs known as TNF blockers. It works by blocking a protein (tumor necrosis factor - TNF) in your body's immune system that causes joint swelling and damage. Golimumab helps slow joint damage and reduce joint pain/swelling so you can move better.

Regulatory & Marketing

Labeler Name
Janssen Biotech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125433
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-19-2013
Listing Expiration
12-31-2026
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 (57894-350). Click a package code to view its specific billing and regulatory data.

57894-350-89
1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE

* 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 57894-350-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose of Simponi Aria, a human prescription drug labeled by Janssen Biotech, Inc.. This solution is formulated for intravenous 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 July 19, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat certain types of arthritis (such as rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis). Golimumab belongs to a class of drugs known as TNF blockers. It works by blocking a protein (tumor necrosis factor - TNF) in your body's immune system that causes joint swelling and damage. Golimumab helps slow joint damage and reduce joint pain/swelling so you can move better.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57894035001. 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)
57894-350-01
11-Digit CMS (5-4-2)
57894-0350-01

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