Fluzone High-Dose Quadrivalent Northern Hemisphere

Product NDC
49281-226
11-digit product format
492810226
Labeler code
49281
Product ID
49281-226_b72ec1ef-74b9-42b3-b7cf-302a2cb07409
Type
VACCINE
Nonproprietary 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)
Dosage form
INJECTION, SUSPENSION
Route
INTRAMUSCULAR
Labeler
Sanofi Pasteur Inc.
Application
BLA103914
Marketing category
BLA
Marketing start
2025-07-01
Marketing end
2026-06-30
Substance
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active strength
60; 60; 60; 60 ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termMatched term
B93BQX9789INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49281-226-654928102266510 SYRINGE, GLASS in 1 PACKAGE (49281-226-65) / .7 mL in 1 SYRINGE, GLASS (49281-226-88) 2025-07-012026-06-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Fluzone High-Dose Quadrivalent Northern HemisphereSanofi Pasteur Inc.2025-07-11VACCINE LABEL20