Flucelvax Injection, Suspension
NDC Package 85766-263-10

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

Package Information

Flucelvax (influenza a virus a/tasmania/318/2025 cvr-351 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/tasmania/787/2025 cvr-388 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/arizona/21/2025 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 Sportpharm Llc, this product is identified by NDC 85766-263 and is authorized under FDA application BLA125408.

Identification & Billing

NDC Package Code
85766-263-10
Package Description
10 SYRINGE, GLASS in 1 CARTON / .5 mL in 1 SYRINGE, GLASS (85766-263-01)
Product Code
85766-263
11-Digit Billing Format
85766026310

Clinical Specifications

Proprietary Name
Flucelvax
Non-Proprietary Name
Influenza A Virus A/tasmania/318/2025 Cvr-351 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/tasmania/787/2025 Cvr-388 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/arizona/21/2025 Antigen (mdck Cell Derived, Propiolactone Inactivated)
Substance Name
Influenza A Virus A/tasmania/318/2025 Cvr-351 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza A Virus A/tasmania/787/2025 Cvr-388 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza B Virus - B/arizona/21/2025 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
Sportpharm Llc
Product Type
Vaccine
FDA Application #
BLA125408
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
07-01-2026
End Marketing Date
07-31-2027
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 85766-263-10 identifies a specific commercial package of 10 syringe, glass in 1 carton / .5 ml in 1 syringe, glass (85766-263-01) of Flucelvax, a vaccine label labeled by Sportpharm Llc. This injection, suspension is formulated for intramuscular use and contains influenza a virus a/tasmania/318/2025 cvr-351 (h1n1) antigen (mdck cell derived, propiolactone inactivated); influenza a virus a/tasmania/787/2025 cvr-388 (h3n2) antigen (mdck cell derived, propiolactone inactivated); influenza b virus - b/arizona/21/2025 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 Sportpharm Llc on July 01, 2026.

How is this Sportpharm Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85766026310. 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)
85766-263-10
11-Digit CMS (5-4-2)
85766-0263-10

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