# FLUBLOK TRIVALENT NORTHERN HEMISPHERE (INFLUENZA A VIRUS A/Missouri/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, I) by Sanofi Vaccines US Inc.: new vaccine listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | FLUBLOK TRIVALENT NORTHERN HEMISPHERE |
| Generic name | INFLUENZA A VIRUS A/Missouri/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/Darwin/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/Pennsylvania/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN |
| NDC | 49281-726 |
| Labeler | Sanofi Vaccines US Inc. |
| Product type | VACCINE |
| Approval pathway | BLA |
| Application number | BLA125285 |
| Dosage form | INJECTION |
| Route | INTRAMUSCULAR |
| Active ingredients | INFLUENZA A VIRUS A/MISSOURI/11/2025 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug/.5mL; INFLUENZA A VIRUS A/DARWIN/1415/2025 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug/.5mL; INFLUENZA B VIRUS B/PENNSYLVANIA/14/2025 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug/.5mL |
| Marketing start | 2026-07-02 |
| 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=49281-726). 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comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn.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.