Golimumab Solution
NDC Package 65267-899-00

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Golimumab solution 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 solution delivery system. Marketed by Janssen Pharmaceutical Sciences Unlimited Company, this product is identified by NDC 65267-899.

Identification & Billing

NDC Package Code
65267-899-00
Package Description
100 mg in 1 BOTTLE
Product Code
65267-899
11-Digit Billing Format
65267089900

Clinical Specifications

Proprietary Name
Golimumab
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.
Active Ingredient(s)
GOLIMUMAB 1 mg/mg
Usage Information
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).

Regulatory & Marketing

Labeler Name
Janssen Pharmaceutical Sciences Unlimited Company
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-24-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65267-899-00 identifies a specific commercial package of 100 mg in 1 bottle of Golimumab (UNFINISHED drug), a bulk ingredient labeled by Janssen Pharmaceutical Sciences Unlimited Company. This solution is formulated for 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 Pharmaceutical Sciences Unlimited Company on April 24, 2009. The current certification is valid through December 31, 2026.

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 Pharmaceutical Sciences Unlimited Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65267089900. 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)
65267-899-00
11-Digit CMS (5-4-2)
65267-0899-00

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