FDA.reportPublic FDA data

FLUZONE HIGH DOSE NORTHERN HEMISPHERE

Manufacturer
Patheon Manufacturing Services LLC
Effective date
2025-11-04
Label type
VACCINE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:32

Label at a glance#

ProductFLUZONE HIGH DOSE NORTHERN HEMISPHERE
Active ingredientINFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FluzoneFluzone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2718469Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled SyringePSN1
2709013influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled SyringePSN1
27184690.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled Syringe [Fluzone 2025-2026]SBD1
27090130.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.12 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.12 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.12 MG/ML Prefilled SyringeSCD1
2718469Fluzone 2025-2026 high-dose vaccine 0.5 ML Prefilled SyringeSY1
2709013influenza virus vaccine 2025 high dose (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled SyringeSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix934379Fluzone label 49281-125-65.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63552-722-05FLUZONE HIGH DOSE NORTHERN HEMISPHERE0.5 mL in 1 SYRINGE, GLASSINJECTION, SUSPENSION0.51
63552-722-10FLUZONE HIGH DOSE NORTHERN HEMISPHERE5 in 1 PACKAGEINJECTION, SUSPENSION51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63552-72263552-722-05, 63552-722-10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103914Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone QuadrivalentInfluenza Virus Vaccine351(a)Rx2026-09-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)HQW9FZS4YKACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)FF9YP4D23CACTIM
OCTOXYNOL-97JPC6Y25QSIACT
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)AU5C98U4BBACTIM
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
WATER059QF0KO0RIACT
FORMALDEHYDE1HG84L3525IACT

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.