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NDC 58160-848 Arexvy

Respiratory Syncytial Visus Vaccine Recombinant,Adjuvanted Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 58160-848?
  5. Arexvy Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
58160-848
Proprietary Name:
Arexvy
Non-Proprietary Name: [1]
Respiratory Syncytial Visus Vaccine Recombinant, Adjuvanted
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:
1e50f275-002e-413f-a840-66ee3cb3740c
FDA Application Number: [6]
BLA125775
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
05-03-2023
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)

Product Packages

NDC Code 58160-848-11

Package Description: 1 KIT in 1 CARTON * .5 mL in 1 VIAL (58160-723-03) * .5 mL in 1 VIAL (58160-744-03)

Product Details

What is NDC 58160-848?

The NDC code 58160-848 is assigned by the FDA to the product Arexvy which is a vaccine label product labeled by Glaxosmithkline Biologicals Sa. The generic name of Arexvy is respiratory syncytial visus vaccine recombinant, adjuvanted. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 58160-848-11 1 kit in 1 carton * .5 ml in 1 vial (58160-723-03) * .5 ml in 1 vial (58160-744-03). 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 Arexvy?

AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.

Which are Arexvy UNII Codes?

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

  • RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN (UNII: M739EB7427)
  • RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN (UNII: M739EB7427) (Active Moiety)

Which are Arexvy 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 Arexvy?

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: 2636593 - respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection
  • RxCUI: 2636593 - 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection
  • RxCUI: 2636599 - AREXVY 120 MCG per 0.5 ML Injection
  • RxCUI: 2636599 - 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection [Arexvy]
  • RxCUI: 2636599 - 0.5 ML Arexvy 0.24 MG/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".