Kineret Injection, Solution
NDC Package 66658-234-28

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

Kineret (anakinra) injection is a medication used alone or with other medications to treat rheumatoid arthritis. This formulation utilizes a injection, solution delivery system. Marketed by Swedish Orphan Biovitrum Ab (publ), this product is identified by NDC 66658-234 and is authorized under FDA application BLA103950.

Identification & Billing

NDC Package Code
66658-234-28
Package Description
4 CARTON in 1 CASE / 7 SYRINGE, GLASS in 1 CARTON / .67 mL in 1 SYRINGE, GLASS
Product Code
66658-234
11-Digit Billing Format
66658023428
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kineret
Non-Proprietary Name
Anakinra
Substance Name
Anakinra
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)
ANAKINRA 100 mg/.67mL
Pharmacologic Class
Usage Information
This medication is used alone or with other medications to treat rheumatoid arthritis. It helps to slow joint damage and reduces the joint pain/swelling caused by rheumatoid arthritis so that you can move better. Anakinra is a man-made form of a natural protein (interleukin-1 receptor antagonist) made by the body. It helps to block the effects of another protein (interleukin-1) which can cause joint pain/swelling/stiffness. Anakinra is also used to treat a certain condition called Neonatal-Onset Multisystem Inflammatory Disease (NOMID). It helps to improve symptoms of the disease such as fever, rash, joint pain, vomiting, and headache.

Regulatory & Marketing

Labeler Name
Swedish Orphan Biovitrum Ab (publ)
Product Type
Human Prescription Drug
FDA Application #
BLA103950
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-15-2009
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 (66658-234). Click a package code to view its specific billing and regulatory data.

66658-234-07
7 SYRINGE, GLASS in 1 CARTON / .67 mL in 1 SYRINGE, GLASS

* 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 66658-234-28 identifies a specific commercial package of 4 carton in 1 case / 7 syringe, glass in 1 carton / .67 ml in 1 syringe, glass of Kineret, a human prescription drug labeled by Swedish Orphan Biovitrum Ab (publ). This injection, solution is formulated for subcutaneous use and contains anakinra 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 Swedish Orphan Biovitrum Ab (publ) on December 15, 2009. 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 rheumatoid arthritis. It helps to slow joint damage and reduces the joint pain/swelling caused by rheumatoid arthritis so that you can move better. Anakinra is a man-made form of a natural protein (interleukin-1 receptor antagonist) made by the body. It helps to block the effects of another protein (interleukin-1) which can cause joint pain/swelling/stiffness. Anakinra is also used to treat a certain condition called Neonatal-Onset Multisystem Inflammatory Disease (NOMID). It helps to improve symptoms of the disease such as fever, rash, joint pain, vomiting, and headache.

How is this Swedish Orphan Biovitrum Ab (publ) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66658023428. 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)
66658-234-28
11-Digit CMS (5-4-2)
66658-0234-28

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