Flucelvax NDC 85766-263

Product information

Brand name (proprietary)

Flucelvax

Generic name (nonproprietary)

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)

Active ingredients

Influenza a virus a/tasmania/318/2025 cvr-351 (H1n1) antigen (Mdck cell derived, Propiolactone inactivated) — 15 ug/.5mLInfluenza a virus a/tasmania/787/2025 cvr-388 (H3n2) antigen (Mdck cell derived, Propiolactone inactivated) — 15 ug/.5mLInfluenza b virus - b/arizona/21/2025 antigen (Mdck cell derived, Propiolactone inactivated) — 15 ug/.5mL

Dosage form

Injection, Suspension

Route

Intramuscular

Labeler

Sportpharm LLC

Product type

Vaccine

Marketing category

BLA — Biologics License ApplicationApplication BLA 125408

Marketing start

Jul 1, 2026

Marketing end

Jul 31, 2027

Identifiers

Product ID 85766-263_5a564edc-8375-1611-e063-6294a90a0b80SPL ID 5a564edc-8375-1611-e063-6294a90a0b80

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Immunization administration (CPT 90460–90474)

Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.

How CPT relates to drug billing

NDC on a medical claim

N485766026310 followed by a unit qualifier and the quantity Copy

Package 85766-0263-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under BLA 125408

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.