Fluzone Quadrivalent Northern Hemisphere Injection, Suspension
NDC Package 49281-926-50

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

Package Information

Fluzone Quadrivalent Northern Hemisphere (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/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection is fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.Fluzone Quadrivalent is approved for use in persons 6 months of age and older. This formulation utilizes a injection, suspension delivery system. Marketed by Sanofi Pasteur Inc., this product is identified by NDC 49281-926 and is authorized under FDA application BLA103914.

Identification & Billing

NDC Package Code
49281-926-50
Package Description
10 SYRINGE, GLASS in 1 PACKAGE / .5 mL in 1 SYRINGE, GLASS (49281-926-88)
Product Code
49281-926
11-Digit Billing Format
49281092650
RxNorm Crosswalk
  • RxCUI: 2709119 - influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) 0.5 ML Prefilled Syringe
  • RxCUI: 2709119 - 0.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Prefilled Syringe
  • RxCUI: 2709125 - influenza virus vaccine 2025 (quadrivalent - Croatia/Victoria/Michigan/Phuket) Injectable Suspension
  • RxCUI: 2709125 - influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML / influenza B virus B/Phuket/3073/2013 antigen 0.03 MG/ML Injectable Suspension
  • RxCUI: 2719474 - Fluzone Quadrivalent 2025-2026 vaccine Injectable Suspension

Clinical Specifications

Proprietary Name
Fluzone Quadrivalent Northern Hemisphere
Non-Proprietary 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/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
Substance Name
Influenza A Virus A/croatia/10136rv/2023 X-425a (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 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® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.Fluzone Quadrivalent is approved for use in persons 6 months of age and older.

Regulatory & Marketing

Labeler Name
Sanofi Pasteur Inc.
Product Type
Vaccine
FDA Application #
BLA103914
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
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 49281-926-50 identifies a specific commercial package of 10 syringe, glass in 1 package / .5 ml in 1 syringe, glass (49281-926-88) of Fluzone Quadrivalent Northern Hemisphere, a vaccine label labeled by Sanofi Pasteur Inc.. This injection, suspension is formulated for intramuscular use and contains influenza a virus a/croatia/10136rv/2023 x-425a (h3n2) antigen (formaldehyde inactivated); influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated); influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated); influenza b virus b/phuket/3073/2013 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 Pasteur Inc. on July 01, 2025.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49281092650. 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)
49281-926-50
11-Digit CMS (5-4-2)
49281-0926-50

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