Flucelvax Injection, Suspension
NDC Package 70461-655-03

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.

Flucelvax (influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/victoria/800/2024 cvr-289 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone inactivated)) injection is fLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. This formulation utilizes a injection, suspension delivery system. Marketed by Seqirus Inc., this product is identified by NDC 70461-655 and is authorized under FDA application BLA125408.

Identification & Billing

NDC Package Code
70461-655-03
Package Description
10 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (70461-655-04)
Product Code
70461-655
11-Digit Billing Format
70461065503
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2718368 - influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) Injectable Suspension
  • RxCUI: 2718368 - influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension
  • RxCUI: 2718374 - FLUCELVAX 2025-2026 vaccine Injectable Suspension
  • RxCUI: 2718374 - influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026]
  • RxCUI: 2718374 - Flucelvax 2025-2026 vaccine Injectable Suspension

Clinical Specifications

Proprietary Name
Flucelvax
Non-Proprietary Name
Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/victoria/800/2024 Cvr-289 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone Inactivated)
Substance Name
Influenza A Virus A/georgia/12/2022 Cvr-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza A Virus A/victoria/800/2024 Cvr-289 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Propiolactone 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
FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUCELVAX is approved for use in persons 6 months of age and older. [see Clinical Studies (14)]

Regulatory & Marketing

Labeler Name
Seqirus Inc.
Product Type
Vaccine
FDA Application #
BLA125408
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2025
End Marketing Date
07-31-2026
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.

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.

90661
Source: AWP
CCIIV3 VACCINE ABX FR 0.5ML IM
HCPCS Dosage 0.5 ML
Units / Pkg 10

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 70461-655-03 identifies a specific commercial package of 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (70461-655-04) of Flucelvax, a vaccine label labeled by Seqirus Inc.. This injection, suspension is formulated for intramuscular use and contains influenza a virus a/georgia/12/2022 cvr-167 (h1n1) antigen (mdck cell derived, propiolactone inactivated); influenza a virus a/victoria/800/2024 cvr-289 (h3n2) antigen (mdck cell derived, propiolactone inactivated); influenza b virus b/singapore/wuh4618/2021 antigen (mdck cell derived, propiolactone 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 Seqirus Inc. on July 01, 2025.

How is this Seqirus Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70461065503. 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)
70461-655-03
11-Digit CMS (5-4-2)
70461-0655-03

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