FLUZONE HIGH DOSE NORTHERN HEMISPHERE (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen- formaldehyde inactivated injection, suspension

FLUZONE HIGH DOSE NORTHERN HEMISPHERE by

Drug Labeling and Warnings

FLUZONE HIGH DOSE NORTHERN HEMISPHERE by is a Other medication manufactured, distributed, or labeled by Patheon Manufacturing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUZONE HIGH DOSE NORTHERN HEMISPHERE 
influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/croatia/10136/rv/2023 (h3n2) antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 63552-722
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: HQW9FZS4YK) (INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:SD82XNG5M6)	INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug  in 0.5 mL
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: FF9YP4D23C) (INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:CQV855H5FG)	INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug  in 0.5 mL
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: AU5C98U4BB) (INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:C46XJT9FQ9)	INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)	60 ug  in 0.5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
WATER (UNII: 059QF0KO0R)
FORMALDEHYDE (UNII: 1HG84L3525)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63552-722-10	5 in 1 PACKAGE
1	NDC: 63552-722-05	0.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA103914	09/01/2025

Labeler - Patheon Manufacturing Services LLC (079415560)

Registrant - Patheon Manufacturing Services LLC (062331516)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Manufacturing Services LLC		062331516	analysis(63552-722) , label(63552-722) , manufacture(63552-722) , pack(63552-722)