Fluzone Hd Tiv Sh 2026 Injection, Suspension
NDC Package 49281-016-50

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

Package Information

Fluzone Hd Tiv Sh 2026 (influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection is fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older. This formulation utilizes a injection, suspension delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-016 and is authorized under FDA application BLA103914.

Identification & Billing

NDC Package Code
49281-016-50
Package Description
10 SYRINGE, GLASS in 1 PACKAGE / .5 mL in 1 SYRINGE, GLASS (49281-016-88)
Product Code
49281-016
11-Digit Billing Format
49281001650
RxNorm Crosswalk
  • RxCUI: 2738154 - influenza virus vaccine 2026 high dose (trivalent - Singapore/Switzerland/Michigan) 0.5 mL Prefilled Syringe
  • RxCUI: 2738154 - 0.5 ML influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe
  • RxCUI: 2738157 - Fluzone 2026 Southern Hemisphere high dose vaccine 0.5 mL Prefilled Syringe
  • RxCUI: 2738157 - 0.5 ML influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe [Fluzone 2026 Southern Hemisphere]

Clinical Specifications

Proprietary Name
Fluzone Hd Tiv Sh 2026
Non-Proprietary Name
Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
Substance Name
Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
Usage Information
Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.

Regulatory & Marketing

Labeler Name
Sanofi Vaccines Us Inc.
Product Type
Vaccine
FDA Application #
BLA103914
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-20-2026
End Marketing Date
12-31-2026
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 49281-016-50 identifies a specific commercial package of 10 syringe, glass in 1 package / .5 ml in 1 syringe, glass (49281-016-88) of Fluzone Hd Tiv Sh 2026, a vaccine label labeled by Sanofi Vaccines Us Inc.. This injection, suspension is formulated for intramuscular use and contains influenza a virus a/singapore/gp20238/2024 ivr-277 (h3n2) antigen (formaldehyde inactivated); influenza a virus a/switzerland/6849/2025 ivr-278 (h1n1) antigen (formaldehyde inactivated); influenza b virus b/michigan/01/2021 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 Sanofi Vaccines Us Inc. on February 20, 2026.

How is this Sanofi Vaccines Us Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281001650. 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)
49281-016-50
11-Digit CMS (5-4-2)
49281-0016-50

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