Fluzone Trivalent Northern Hemisphere Injection, Suspension
NDC Package 49281-643-15

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Fluzone Trivalent Northern Hemisphere (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated)) injection is fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.Fluzone is approved for use in persons 6 months of age and older. This formulation utilizes a injection, suspension delivery system. Marketed by Sanofi Vaccines Us Inc., this product is identified by NDC 49281-643 and is authorized under FDA application BLA103914.

Identification & Billing

NDC Package Code
49281-643-15
Package Description
1 VIAL, MULTI-DOSE in 1 PACKAGE / 5 mL in 1 VIAL, MULTI-DOSE (49281-643-78)
Product Code
49281-643
11-Digit Billing Format
49281064315
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2709231 - influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) Injectable Suspension
  • RxCUI: 2709231 - 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 Injectable Suspension
  • RxCUI: 2709236 - influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe
  • RxCUI: 2709236 - 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 Prefilled Syringe
  • RxCUI: 2719212 - Fluzone 2025-2026 vaccine 0.5 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Fluzone Trivalent Northern Hemisphere
Non-Proprietary Name
Influenza A Virus A/victoria/4897/2022 Ivr-238 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/croatia/10136/rv/2023 (h3n2) 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)
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® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.Fluzone is approved for use in persons 6 months 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
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

90657
Source: AWP
IIV3 VACCINE SPLT 0.25 ML IM
HCPCS Dosage 0.25 ML
Units / Pkg 20

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 49281-643-15 identifies a specific commercial package of 1 vial, multi-dose in 1 package / 5 ml in 1 vial, multi-dose (49281-643-78) of Fluzone Trivalent Northern Hemisphere, a vaccine label labeled by Sanofi Vaccines Us 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) 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 July 01, 2025.

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: 49281064315. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
49281-643-15
11-Digit CMS (5-4-2)
49281-0643-15

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