Arexvy Kit
NDC Package 58160-894-15

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Arexvy (respiratory syncytial virus vaccine recombinant, adjuvanted) kits is 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. This formulation utilizes a kit delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-894 and is authorized under FDA application BLA125775.

Identification & Billing

NDC Package Code
58160-894-15
Package Description
1 KIT in 1 CARTON * .5 mL in 1 VIAL (58160-719-03) * .5 mL in 1 SYRINGE (58160-749-07)
Product Code
58160-894
11-Digit Billing Format
58160089415
RxNorm Crosswalk
  • RxCUI: 2636593 - respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG in 0.5 ML Injection
  • RxCUI: 2636593 - 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection
  • RxCUI: 2636593 - respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection
  • RxCUI: 2636599 - AREXVY 120 MCG in 0.5 ML Injection
  • RxCUI: 2636599 - 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection [Arexvy]

Clinical Specifications

Proprietary Name
Arexvy
Non-Proprietary Name
Respiratory Syncytial Virus Vaccine Recombinant, Adjuvanted
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA125775
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-30-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58160-894-15 identifies a specific commercial package of 1 kit in 1 carton * .5 ml in 1 vial (58160-719-03) * .5 ml in 1 syringe (58160-749-07) of Arexvy, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Glaxosmithkline Biologicals Sa on April 30, 2026. The current certification is valid through December 31, 2027.

How is this Glaxosmithkline Biologicals Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160089415. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
58160-894-15
11-Digit CMS (5-4-2)
58160-0894-15

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.