NDC Package 58160-912-52 Fluarix 2025/2026

Influenza Virus Vaccine Suspension Intramuscular - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

58160-912-52

Package Description:

10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-912-41)

Product Code:

58160-912

Proprietary Name:

Fluarix 2025/2026

Non-Proprietary Name:

Influenza Virus Vaccine

Substance Name:

Influenza A Virus A/thailand/8/2022 Ivr-237 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated)

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.

11-Digit NDC Billing Format:

58160091252

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Product Type:

Vaccine

Labeler Name:

Glaxosmithkline Biologicals Sa

Dosage Form:

Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Administration Route(s):

Intramuscular - Administration within a muscle.

Active Ingredient(s):

Sample Package:

FDA Application Number:

BLA125127

Marketing Category:

BLA - A product marketed under an approved Biologic License Application.

Start Marketing Date:

07-01-2025

End Marketing Date:

06-30-2026

Exclude Flag:

Code Structure:

58160 - Glaxosmithkline Biologicals Sa
- 58160-912 - Fluarix
  - 58160-912-52 - 10 SYRINGE in 1 CARTON / .5 mL in 1 SYRINGE (58160-912-41)

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 disclaimer below.

Frequently Asked Questions

What is NDC 58160-912-52?

The NDC Packaged Code 58160-912-52 is assigned to a package of 10 syringe in 1 carton / .5 ml in 1 syringe (58160-912-41) of Fluarix 2025/2026, a vaccine label labeled by Glaxosmithkline Biologicals Sa. The product's dosage form is suspension and is administered via intramuscular form.

Is NDC 58160-912 included in the NDC Directory?

Yes, Fluarix 2025/2026 with product code 58160-912 is active and included in the NDC Directory. The product was first marketed by Glaxosmithkline Biologicals Sa on July 01, 2025.

What is the NDC billing unit for package 58160-912-52?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 58160-912-52?

The 11-digit format is 58160091252. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58160-912-52	5-4-2	58160-0912-52

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