Arepanrix Kit
NDC Package 58160-742-25

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

Package Information

Arepanrix (influenza a h5 monovalent vaccine) kits is aREPANRIX is indicated for active immunization for the prevention of disease caused by the influenza A virus H5 subtype contained in the vaccine. This formulation utilizes a kit delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-742 and is authorized under FDA application BLA125419.

Identification & Billing

NDC Package Code
58160-742-25
Package Description
1 KIT in 1 CARTON * 10 VIAL in 1 CARTON (58160-753-19) / 2.5 mL in 1 VIAL (58160-753-01) * 10 VIAL in 1 CARTON (58160-855-19) / 2.5 mL in 1 VIAL (58160-855-01)
Product Code
58160-742
11-Digit Billing Format
58160074225
RxNorm Crosswalk
  • RxCUI: 2743203 - influenza A (H5N8) virus vaccine (monovalent - Astrakhan/3212/2020) Injectable Suspension
  • RxCUI: 2743203 - influenza A virus A/Astrakhan/3212/2020 (H5N8) antigen 0.0075 MG/ML Injectable Suspension
  • RxCUI: 2743209 - AREPANRIX vaccine Injectable Suspension
  • RxCUI: 2743209 - influenza A virus A/Astrakhan/3212/2020 (H5N8) antigen 0.0075 MG/ML Injectable Suspension [Arepanrix]
  • RxCUI: 2743209 - Arepanrix 0.0075 MG/ML Injectable Suspension

Clinical Specifications

Proprietary Name
Arepanrix
Non-Proprietary Name
Influenza A H5 Monovalent Vaccine
Dosage Form
Kit - A packaged collection of related material.
Usage Information
AREPANRIX is indicated for active immunization for the prevention of disease caused by the influenza A virus H5 subtype contained in the vaccine. AREPANRIX is approved for use in individuals 6 months of age and older at increased risk of exposure to the influenza A virus H5 subtype contained in the vaccine.In individuals 6 months through 17 years of age, this indication is approved under accelerated approval based on immune responses, as measured by hemagglutination‑inhibition (HI) titers [see Clinical Studies (14.2)]. Continued approval for this indication in individuals 6 months through 17 years of age may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA125419
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-11-2026
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 58160-742-25 identifies a specific commercial package of 1 kit in 1 carton * 10 vial in 1 carton (58160-753-19) / 2.5 ml in 1 vial (58160-753-01) * 10 vial in 1 carton (58160-855-19) / 2.5 ml in 1 vial (58160-855-01) of Arepanrix, 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 May 11, 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: 58160074225. 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)
58160-742-25
11-Digit CMS (5-4-2)
58160-0742-25

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