Basic Information
FLUZONE HIGH DOSE NORTHERN HEMISPHERE
49281-124
Regulatory Information
49281-124
BLA103914
C73585
May 6, 2025
USA
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
VACCINE LABEL
5
Company Information
086723285
Active Ingredients
Quantity: 60 ug in 0.5 mL
Code: AU5C98U4BB
Class Code: ACTIM
Quantity: 60 ug in 0.5 mL
Code: FF9YP4D23C
Class Code: ACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Code: 22ADO53M6F
Class Code: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
Code: KH7I04HPUU
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
OCTOXYNOL-9
Code: 7JPC6Y25QS
Class Code: IACT
FORMALDEHYDE
Code: 1HG84L3525
Class Code: IACT
Quantity: 60 ug in 0.5 mL
Code: N7CB2U8HAC
Class Code: ACTIM
Active Moieties
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: C46XJT9FQ9
INFLUENZA A VIRUS A/CALIFORNIA/122/2022 SAN-022 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: 8L9R8S52VV
INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
Code: CQV855H5FG