# Flucelvax (INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED,) by Sportpharm LLC: new vaccine listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | Flucelvax |
| Generic 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 INAC |
| NDC | 85766-263 |
| Labeler | Sportpharm LLC |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125408 |
| Dosage form | INJECTION, SUSPENSION |
| Route | INTRAMUSCULAR |
| Active ingredients | INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL; INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL; INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug/.5mL |
| Marketing start | 2026-07-01 |
| Package configurations | 1 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=85766-263). Last refreshed: 2026-11-03T18:09:00.764Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.