# FLUZONE HIGH DOSE NORTHERN HEMISPHERE

NDC: 49281-126
Generic name: INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (A/MISSOURI/11/2025 PDM09-LIKE VIRUS) (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
Labeler / Manufacturer: Sanofi Vaccines US Inc.
Product type: VACCINE
Marketing category: Biologic License Application
Dosage form: INJECTION, SUSPENSION
Routes: INTRAMUSCULAR
Marketing started: 20260702
Marketing ended: 20270630
FDA application: BLA103914

## Active ingredients

- INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED): 60 ug/.5mL
- INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED): 60 ug/.5mL
- INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED): 60 ug/.5mL

## Pharmacological class

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## External sources

- openFDA: https://api.fda.gov/drug/ndc.json?search=product_ndc:"49281-126"
- FDA NDC Directory: https://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm?p_ndc=49281-126