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  4. NDC Product Code: 42515-003 Ixchiq

NDC 42515-003 Ixchiq

Chikungunya Vaccine,Live-attenuated Injection, Powder, Lyophilized, For Solution - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 42515-003?
  4. Ixchiq Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
42515-003
Proprietary Name:
Ixchiq
Non-Proprietary Name: [1]
Chikungunya Vaccine, Live-attenuated
Substance Name: [2]
Chikungunya Virus Lr2006 Opy1 (attenuated Strain) Antigen
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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(s): [4]
  • Intramuscular - Administration within a muscle.
    • Labeler Name: [5]
    Valneva Scotland Ltd.
    Labeler Code:
    42515
    Product Label ID:
    63d5cd82-02e3-4436-b81a-12d45bb6a90b
    FDA Application Number: [6]
    BLA125777
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-15-2024
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Code Structure Chart

    Product Details

    What is NDC 42515-003?

    The NDC code 42515-003 is assigned by the FDA to the product Ixchiq which is a vaccine label product labeled by Valneva Scotland Ltd.. The generic name of Ixchiq is chikungunya vaccine, live-attenuated. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intramuscular form. The product is distributed in a single package with assigned NDC code 42515-003-01 1 syringe in 1 carton / .5 ml in 1 syringe (42515-003-00). 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 Ixchiq?

    IXCHIQ is a vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody levels [See Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.

    What are Ixchiq Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Ixchiq UNII Codes?

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

    • CHIKUNGUNYA VIRUS LR2006 OPY1 (ATTENUATED STRAIN) ANTIGEN (UNII: 2RM4VT46R8)
    • CHIKUNGUNYA VIRUS LR2006 OPY1 (ATTENUATED STRAIN) ANTIGEN (UNII: 2RM4VT46R8) (Active Moiety)

    What is the NDC to RxNorm Crosswalk for Ixchiq?

    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: 2673242 - chikungunya virus vaccine live 0.5 ML Injection
    • RxCUI: 2673242 - chikungunya virus antigen, live attenuated LR2006 OPY1 strain 2000 UNT Injection
    • RxCUI: 2673247 - IXCHIQ vaccine live 0.5 ML Injection
    • RxCUI: 2673247 - chikungunya virus antigen, live attenuated LR2006 OPY1 strain 2000 UNT Injection [Ixchiq]
    • RxCUI: 2673247 - Ixchiq 2000 UNT Injection

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".