Ixiaro Injection, Suspension
NDC Package 42515-002-01

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

Package Information

Ixiaro (japanese encephalitis vaccine, inactivated, adsorbed) injection is iXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). This formulation utilizes a injection, suspension delivery system. Marketed by Valneva Scotland Ltd., this product is identified by NDC 42515-002 and is authorized under FDA application BLA125280.

Identification & Billing

NDC Package Code
42515-002-01
Package Description
.5 mL in 1 SYRINGE
Product Code
42515-002
11-Digit Billing Format
42515000201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
0.5 ML
RxNorm Crosswalk
  • RxCUI: 1300781 - Japanese encephalitis vaccine 6 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 1300781 - 0.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe
  • RxCUI: 1300781 - Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 6 MCG per 0.5 ML Prefilled Syringe
  • RxCUI: 1300783 - IXIARO 6 MCG in 0.5 ML Prefilled Syringe
  • RxCUI: 1300783 - 0.5 ML Japanese encephalitis virus vaccine Nakayama-NIH strain, inactivated 0.012 MG/ML Prefilled Syringe [Ixiaro]

Clinical Specifications

Proprietary Name
Ixiaro
Non-Proprietary Name
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Substance Name
Japanese Encephalitis Virus Strain Sa 14-14-2 Antigen (formaldehyde Inactivated)
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) 6 [arb'U]/.5mL
Pharmacologic Class
Usage Information
IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.

Regulatory & Marketing

Labeler Name
Valneva Scotland Ltd.
Product Type
Vaccine
FDA Application #
BLA125280
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-30-2009
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42515-002-01 identifies a specific commercial package of .5 ml in 1 syringe of Ixiaro, a vaccine label labeled by Valneva Scotland Ltd.. This product is billed per "ML" milliliter and contains an estimated amount of 0.5 billable units per package. This injection, suspension is formulated for intramuscular use and contains japanese encephalitis virus strain sa 14-14-2 antigen (formaldehyde inactivated) 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 Valneva Scotland Ltd. on March 30, 2009. The current certification is valid through December 31, 2026.

How is this Valneva Scotland Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42515000201. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 0.5 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)
42515-002-01
11-Digit CMS (5-4-2)
42515-0002-01

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