NDC 0024-5910 Kevzara
Sarilumab Injection, Solution Subcutaneous

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0024-5910?
    4. Kevzara Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0024-5910
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Kevzara
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Sarilumab
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Sarilumab
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormInjection, 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(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Sanofi-aventis U.s. Llc
Labeler Code0024
SPL SET ID:827bc01c-d379-4266-a18c-c7f904b76af3
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		BLA761037
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		05-22-2017
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Packages

NDC Code 0024-5910-01

Package Description: 2 SYRINGE in 1 PACKAGE / 1.14 mL in 1 SYRINGE (0024-5910-00)

NDC Code 0024-5910-02

Package Description: 2 SYRINGE in 1 PACKAGE / 1.14 mL in 1 SYRINGE

Product Details

What is NDC 0024-5910?

The NDC code 0024-5910 is assigned by the FDA to the product Kevzara which is a human prescription drug product labeled by Sanofi-aventis U.s. Llc. The generic name of Kevzara is sarilumab. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 0024-5910-01 2 syringe in 1 package / 1.14 ml in 1 syringe (0024-5910-00), 0024-5910-02 2 syringe in 1 package / 1.14 ml in 1 syringe. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Kevzara?

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.

What are Kevzara Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Kevzara UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Kevzara Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Kevzara?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes for Kevzara?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Sarilumab Injection


Sarilumab injection is used alone or with other medications to treat rheumatoid arthritis (RA: condition in which the body attacks its own joints causing pain, swelling, and loss of function). Sarilumab is usually used by people who were not helped by certain other drugs for RA or who could not take these medications. Sarilumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works by blocking the activity of interleukin-6, a substance in the body that causes inflammation.
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Product Label

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