Arcalyst Injection, Powder, Lyophilized, For Solution
NDC Package 73604-914-04

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

Arcalyst (rilonacept) injection is a medication used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Kiniksa Pharmaceuticals (uk), Ltd., this product is identified by NDC 73604-914 and is authorized under FDA application BLA125249.

Identification & Billing

NDC Package Code
73604-914-04
Package Description
4 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE
Product Code
73604-914
11-Digit Billing Format
73604091404
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Arcalyst
Non-Proprietary Name
Rilonacept
Substance Name
Rilonacept
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
RILONACEPT 160 mg/2mL
Usage Information
This medication is used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Rilonacept works by blocking a certain natural protein in your body (interleukin-1) that may worsen the symptoms of CAPS. Rilonacept does not cure CAPS, but it can help lessen the symptoms, including rash, joint pain, fever, and tiredness.

Regulatory & Marketing

Labeler Name
Kiniksa Pharmaceuticals (uk), Ltd.
Product Type
Human Prescription Drug
FDA Application #
BLA125249
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-27-2008
Listing Expiration
12-31-2026
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 (73604-914). Click a package code to view its specific billing and regulatory data.

73604-914-01
1 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE

* 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 73604-914-04 identifies a specific commercial package of 4 vial, single-use in 1 carton / 2 ml in 1 vial, single-use of Arcalyst, a human prescription drug labeled by Kiniksa Pharmaceuticals (uk), Ltd.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for subcutaneous use and contains rilonacept 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 Kiniksa Pharmaceuticals (uk), Ltd. on February 27, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Rilonacept works by blocking a certain natural protein in your body (interleukin-1) that may worsen the symptoms of CAPS. Rilonacept does not cure CAPS, but it can help lessen the symptoms, including rash, joint pain, fever, and tiredness.

How is this Kiniksa Pharmaceuticals (uk), Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73604091404. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
73604-914-04
11-Digit CMS (5-4-2)
73604-0914-04

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