FLUZONE QIV SH 2025
These highlights do not include all the information needed to use Fluzone Quadrivalent Southern Hemisphere safely and effectively. See full prescribing information for Fluzone Quadrivalent Southern Hemisphere. Fluzone Quadrivalent (Influenza Vaccine) injectable suspension, for intramuscular use 2025 Formula Initial U.S. Approval: 2013
Approved
Approval ID
d041603b-fa96-433c-a9bc-5393aab4a289
Product Type
VACCINE LABEL
Effective Date
Mar 21, 2025
Manufacturers
FDA
Sanofi Pasteur Inc.
DUNS: 086723285
Products 2
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/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 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 Code49281-326
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/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 21, 2025
FDA Product Classification
INGREDIENTS (10)
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: AU5C98U4BB
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: B93BQX9789
Classification: ACTIM
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 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/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: HQW9FZS4YK
Classification: ACTIM
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 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 Code49281-357
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/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 21, 2025
FDA Product Classification
INGREDIENTS (11)
THIMEROSALInactive
Code: 2225PI3MOV
Classification: IACT
OCTOXYNOL-9Inactive
Code: 7JPC6Y25QS
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: AU5C98U4BB
Classification: ACTIM
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: B93BQX9789
Classification: ACTIM
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: FF9YP4D23C
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Code: KH7I04HPUU
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
FORMALDEHYDEInactive
Code: 1HG84L3525
Classification: IACT
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 15 ug in 0.5 mL
Code: HQW9FZS4YK
Classification: ACTIM