Sarilumab Injection, Solution
NDC Package 51789-924-00

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.

Sarilumab injection is a medication used alone or with other medications to treat moderate to severe rheumatoid arthritis. This formulation utilizes a injection, solution delivery system. Marketed by Sanofi Winthrop Industrie, this product is identified by NDC 51789-924.

Identification & Billing

NDC Package Code
51789-924-00
Package Description
2 SYRINGE in 1 CARTON / 1.14 mL in 1 SYRINGE
Product Code
51789-924
11-Digit Billing Format
51789092400

Clinical Specifications

Proprietary Name
Sarilumab
Non-Proprietary Name
Sarilumab
Substance Name
Sarilumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Active Ingredient(s)
SARILUMAB 200 mg/1.14mL
Usage Information
This medication is used alone or with other medications to treat moderate to severe rheumatoid arthritis. It helps to reduce pain and swelling due to rheumatoid arthritis. Sarilumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking Interleukin-6, a substance made by the body that causes swelling (inflammation) in areas affected by rheumatoid arthritis.

Regulatory & Marketing

Labeler Name
Sanofi Winthrop Industrie
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-22-2017
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 51789-924-00 identifies a specific commercial package of 2 syringe in 1 carton / 1.14 ml in 1 syringe of Sarilumab (UNFINISHED drug), drug for further processing labeled by Sanofi Winthrop Industrie. This injection, solution is formulated for use and contains sarilumab 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 Sanofi Winthrop Industrie on May 22, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used alone or with other medications to treat moderate to severe rheumatoid arthritis. It helps to reduce pain and swelling due to rheumatoid arthritis. Sarilumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking Interleukin-6, a substance made by the body that causes swelling (inflammation) in areas affected by rheumatoid arthritis.

How is this Sanofi Winthrop Industrie product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51789092400. 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)
51789-924-00
11-Digit CMS (5-4-2)
51789-0924-00

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