1. Home
  2. Labeler Index
  3. Valneva Scotland Ltd.
  4. NDC Product Code: 42515-001 Ixiaro

NDC 42515-001 Ixiaro

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 42515-001?
  4. Ixiaro Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Get all the details for National Drug Code (NDC) 42515-001 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
42515-001
Proprietary Name:
Ixiaro
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Valneva Scotland Ltd.
Labeler Code:
42515
Product Label ID:
b68b7911-628d-4932-b0e8-4ae72c48f92f
FDA Application Number: [6]
BLA125280
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
03-30-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Code Structure Chart

Product Details

What is NDC 42515-001?

The NDC code 42515-001 is assigned by the FDA to the product Ixiaro which is product labeled by Valneva Scotland Ltd.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 42515-001-01 .5 ml in 1 syringe . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Ixiaro?

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.

Which are Ixiaro UNII Codes?

The UNII codes for the active ingredients in this product are:

  • JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: DZ854I04ZE)
  • JAPANESE ENCEPHALITIS VIRUS STRAIN SA 14-14-2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: DZ854I04ZE) (Active Moiety)

Which are Ixiaro Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Ixiaro?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

* Please review the disclaimer below.

Patient Education

Japanese Encephalitis Vaccine


What is Japanese encephalitis? Japanese encephalitis (JE) is a serious infection caused by the Japanese encephalitis virus. It occurs mainly in rural parts of Asia. It is spread through the bite of an infected mosquito. It does not spread from person to person. Risk is very low for most travelers. It is higher for people living in areas where the disease is common, or for people traveling there for long periods of time. Most people infected with JE virus don't have any symptoms. Others might have symptoms as mild as a fever and headache, or as serious as encephalitis (brain infection). A person with encephalitis can experience fever, neck stiffness, seizures, and coma. About 1 person in 4 with encephalitis dies. Up to half of those who don't die have permanent disability. It is believed that infection in a pregnant woman could harm her unborn baby. JE vaccine can help protect travelers from JE disease.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".