FLUZONE HIGH DOSE NORTHERN HEMISPHERE
These highlights do not include all the information needed to use Fluzone High-Dose safely and effectively. See full prescribing information for Fluzone High-Dose. Fluzone High-Dose (Influenza Vaccine) Injectable Suspension, for Intramuscular Use 2024–2025 FormulaInitial U.S. Approval: 2009
Approved
Approval ID
de0e2089-f781-4d47-99f5-c2a1b7b0f1eb
Product Type
VACCINE LABEL
Effective Date
May 6, 2025
Manufacturers
FDA
Sanofi Pasteur Inc.
DUNS: 086723285
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/California/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49281-124
Application NumberBLA103914
Product Classification
M
Marketing Category
C73585
G
Generic Name
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/California/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMay 6, 2025
FDA Product Classification
INGREDIENTS (8)
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 60 ug in 0.5 mL
Code: AU5C98U4BB
Classification: ACTIM
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 60 ug in 0.5 mL
Code: FF9YP4D23C
Classification: ACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTOXYNOL-9Inactive
Code: 7JPC6Y25QS
Classification: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525
Classification: IACT
INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 60 ug in 0.5 mL
Code: N7CB2U8HAC
Classification: ACTIM