Ilaris
NDC Package 0078-0582-61

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ilaris is a medication used to treat certain types of periodic fever syndromes, which include cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0582 and is authorized under FDA application BLA125319.

Identification & Billing

NDC Package Code
0078-0582-61
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code
0078-0582
11-Digit Billing Format
00078058261
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Ilaris
Dosage Form
-
Usage Information
This medication is used to treat certain types of periodic fever syndromes, which include cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). Canakinumab works by blocking a certain natural protein in your body (interleukin-1 beta) that may worsen the symptoms of these diseases. Canakinumab may help to lessen the symptoms, such as rash, joint/muscle pain, fever, eye redness, and tiredness. Canakinumab is also used to treat a type of rheumatoid arthritis in children (systemic juvenile idiopathic arthritis-SJIA), as well as Still's Disease in adults.

Regulatory & Marketing

Labeler Name
Novartis Pharmaceuticals Corporation
FDA Application #
BLA125319
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-18-2009
End Marketing Date
06-19-2020
Listing Expiration
06-19-2020
Exclude Flag
D
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0078-0582-61 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Ilaris, labeled by Novartis Pharmaceuticals Corporation. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Novartis Pharmaceuticals Corporation on June 18, 2009. The current certification is valid through June 19, 2020.

What are the primary indications for this medication?

This medication is used to treat certain types of periodic fever syndromes, which include cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). Canakinumab works by blocking a certain natural protein in your body (interleukin-1 beta) that may worsen the symptoms of these diseases. Canakinumab may help to lessen the symptoms, such as rash, joint/muscle pain, fever, eye redness, and tiredness. Canakinumab is also used to treat a type of rheumatoid arthritis in children (systemic juvenile idiopathic arthritis-SJIA), as well as Still's Disease in adults.

How is this Novartis Pharmaceuticals Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00078058261. 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 (4-4-2)
0078-0582-61
11-Digit CMS (5-4-2)
00078-0582-61

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