Fluarix Suspension
NDC Package 58160-725-52

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

Package Information

Fluarix (influenza virus vaccine) suspension is fLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. This formulation utilizes a suspension delivery system. Marketed by Glaxosmithkline Biologicals Sa, this product is identified by NDC 58160-725 and is authorized under FDA application BLA125127.

Identification & Billing

NDC Package Code
58160-725-52
Package Description
10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-725-41)
Product Code
58160-725
11-Digit Billing Format
58160072552

Clinical Specifications

Proprietary Name
Fluarix 2026/2027
Non-Proprietary Name
Influenza Virus Vaccine
Substance Name
Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated); Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated)
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Usage Information
FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine [see Description (11)]. FLUARIX is approved for use in persons aged 6 months and older.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Biologicals Sa
Product Type
Vaccine
FDA Application #
BLA125127
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2026
End Marketing Date
06-30-2027
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 58160-725-52 identifies a specific commercial package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-725-41) of Fluarix 2026/2027, a vaccine label labeled by Glaxosmithkline Biologicals Sa. This suspension is formulated for intramuscular use and contains influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated); influenza a virus a/croatia/10136rv/2023 x-425a (h3n2) antigen (formaldehyde inactivated); influenza b virus b/austria/1359417/2021 bvr-26 antigen (formaldehyde inactivated) 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 July 01, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58160072552. 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)
58160-725-52
11-Digit CMS (5-4-2)
58160-0725-52

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