Kevzara Injection, Solution
NDC Package 0024-5908-01

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

Kevzara (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-aventis U.s. Llc, this product is identified by NDC 0024-5908 and is authorized under FDA application BLA761037.

Identification & Billing

NDC Package Code
0024-5908-01
Package Description
2 SYRINGE in 1 PACKAGE / 1.14 mL in 1 SYRINGE (0024-5908-00)
Product Code
0024-5908
11-Digit Billing Format
00024590801
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kevzara
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.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
SARILUMAB 150 mg/1.14mL
Pharmacologic Class
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-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761037
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-22-2017
Listing Expiration
12-31-2027
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 (0024-5908). Click a package code to view its specific billing and regulatory data.

0024-5908-02
2 SYRINGE in 1 PACKAGE / 1.14 mL in 1 SYRINGE

* 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 0024-5908-01 identifies a specific commercial package of 2 syringe in 1 package / 1.14 ml in 1 syringe (0024-5908-00) of Kevzara, a human prescription drug labeled by Sanofi-aventis U.s. Llc. This injection, solution is formulated for subcutaneous 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-aventis U.s. Llc on May 22, 2017. The current certification is valid through December 31, 2027.

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-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00024590801. 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 (4-4-2)
0024-5908-01
11-Digit CMS (5-4-2)
00024-5908-01

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