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NDC 58160-824 Priorix

Measels,Mumps,And Rubella Vaccine,Live Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58160-824?
  5. Priorix Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
58160-824
Proprietary Name:
Priorix
Non-Proprietary Name: [1]
Measels, Mumps, And Rubella 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]
Glaxosmithkline Biologicals Sa
Labeler Code:
58160
Product Label ID:
95c6fdb6-b587-4413-92f9-d592b9f7a23e
FDA Application Number: [6]
BLA125748
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
06-03-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITISH TO SLIGHTLY PINK)

Code Structure Chart

Product Details

What is NDC 58160-824?

The NDC code 58160-824 is assigned by the FDA to the product Priorix which is a vaccine label product labeled by Glaxosmithkline Biologicals Sa. The generic name of Priorix is measels, mumps, and rubella vaccine, live. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 58160-824-15 1 kit in 1 carton * .5 ml in 1 vial (58160-831-03) * .5 ml in 1 syringe (58160-833-02). 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 Priorix?

PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

Which are Priorix UNII Codes?

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

  • MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED (UNII: YRF2UZG52M)
  • MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED (UNII: YRF2UZG52M) (Active Moiety)
  • MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK (UNII: 566FJ5L8R4)
  • MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK (UNII: 566FJ5L8R4) (Active Moiety)
  • RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (UNII: 52202H034Z)
  • RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (UNII: 52202H034Z) (Active Moiety)

Which are Priorix 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 Priorix?

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: 2603508 - measles, mumps, and rubella virus vaccine live (generic for Priorix) 0.5 ML Injection
  • RxCUI: 2603508 - 0.5 ML measles virus vaccine live, attenuated Schwarz strain 5024 UNT/ML / mumps virus vaccine live, RIT-4385 strain 31684 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 3990 UNT/ML Injection
  • RxCUI: 2603514 - PRIORIX vaccine 0.5 ML Injection
  • RxCUI: 2603514 - 0.5 ML measles virus vaccine live, attenuated Schwarz strain 5024 UNT/ML / mumps virus vaccine live, RIT-4385 strain 31684 UNT/ML / rubella virus vaccine live (Wistar RA 27-3 strain) 3990 UNT/ML Injection [Priorix]
  • RxCUI: 2603514 - Priorix Measles, Mumps, and Rubella Virus Vaccine Live 0.5 ML 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.

[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".