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NDC 49281-605 Dengvaxia

Dengue Tetravalent Vaccine,Live Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49281-605?
  4. Dengvaxia Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
49281-605
Proprietary Name:
Dengvaxia
Non-Proprietary Name: [1]
Dengue Tetravalent Vaccine, Live
NDC Directory Status:
Vaccine
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Sanofi Pasteur Inc.
Labeler Code:
49281
Product Label ID:
280ee057-3488-4d77-b510-8bc733eeca1e
FDA Application Number: [6]
BLA125682
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
05-01-2019
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 49281-605?

The NDC code 49281-605 is assigned by the FDA to the product Dengvaxia which is a vaccine label product labeled by Sanofi Pasteur Inc.. The generic name of Dengvaxia is dengue tetravalent vaccine, live. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 49281-605-01 1 kit in 1 carton * .5 ml in 1 vial, single-dose (49281-606-58) * .6 ml in 1 vial, single-dose (49281-549-58). 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 Dengvaxia?

DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Which are Dengvaxia UNII Codes?

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

  • CYD DENGUE VIRUS SEROTYPE 1 LIVE (ATTENUATED) ANTIGEN (UNII: 75KB2HPX5H)
  • CYD DENGUE VIRUS SEROTYPE 1 LIVE (ATTENUATED) ANTIGEN (UNII: 75KB2HPX5H) (Active Moiety)
  • CYD DENGUE VIRUS SEROTYPE 2 LIVE (ATTENUATED) ANTIGEN (UNII: FH5SVG7GLC)
  • CYD DENGUE VIRUS SEROTYPE 2 LIVE (ATTENUATED) ANTIGEN (UNII: FH5SVG7GLC) (Active Moiety)
  • CYD DENGUE VIRUS SEROTYPE 3 LIVE (ATTENUATED) ANTIGEN (UNII: RHT2Q37FYG)
  • CYD DENGUE VIRUS SEROTYPE 3 LIVE (ATTENUATED) ANTIGEN (UNII: RHT2Q37FYG) (Active Moiety)
  • CYD DENGUE VIRUS SEROTYPE 4 LIVE (ATTENUATED) ANTIGEN (UNII: RS26HP5ND2)
  • CYD DENGUE VIRUS SEROTYPE 4 LIVE (ATTENUATED) ANTIGEN (UNII: RS26HP5ND2) (Active Moiety)

Which are Dengvaxia 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 Dengvaxia?

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: 2197701 - dengue tetravalent vaccine live 0.5 mL Injection
  • RxCUI: 2197701 - dengue virus live antigen, CYD serotype 1 100000 UNT / dengue virus live antigen, CYD serotype 2 100000 UNT / dengue virus live antigen, CYD serotype 3 100000 UNT / dengue virus live antigen, CYD serotype 4 100000 UNT Injection
  • RxCUI: 2197701 - dengue tetravalent vaccine live 0.5 ML Injection
  • RxCUI: 2197703 - dengvaxia tetravalent vaccine live 0.5 ML Injection
  • RxCUI: 2197703 - dengue virus live antigen, CYD serotype 1 100000 UNT / dengue virus live antigen, CYD serotype 2 100000 UNT / dengue virus live antigen, CYD serotype 3 100000 UNT / dengue virus live antigen, CYD serotype 4 100000 UNT Injection [Dengvaxia]

* 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.

[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.

[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".