Ilaris Injection, Solution
NDC Package 0078-0734-61

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Ilaris (canakinumab) injection 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). This formulation utilizes a injection, solution delivery system. Marketed by Novartis Pharmaceuticals Corporation, this product is identified by NDC 0078-0734 and is authorized under FDA application BLA125319.

Identification & Billing

NDC Package Code
0078-0734-61
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE
Product Code
0078-0734
11-Digit Billing Format
00078073461
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ilaris
Non-Proprietary Name
Canakinumab
Substance Name
Canakinumab
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)
CANAKINUMAB 150 mg/mL
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
Product Type
Human Prescription Drug
FDA Application #
BLA125319
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-22-2016
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0638
Source: PDAC
INJECTION, CANAKINUMAB, 1 MG
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0078-0734-61 identifies a specific commercial package of 1 vial, single-use in 1 carton / 1 ml in 1 vial, single-use of Ilaris, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. This injection, solution is formulated for subcutaneous use and contains canakinumab 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 Novartis Pharmaceuticals Corporation on December 22, 2016. The current certification is valid through December 31, 2027.

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: 00078073461. 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)
0078-0734-61
11-Digit CMS (5-4-2)
00078-0734-61

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