Fluzone (Influenza Vaccine) injectable suspension, for intramuscular use 2025 Formula Initial U.S. Approval: 1980 These highlights do not include all the information needed to use Fluzone ®Southern Hemisphere safely and effectively. See full prescribing information for Fluzone Southern Hemisphere.

FLUZONE TRIVALENT SOUTHERN HEMISPHERE by

Drug Labeling and Warnings

FLUZONE TRIVALENT SOUTHERN HEMISPHERE by is a Other medication manufactured, distributed, or labeled by Bamboo US BidCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLUZONE TRIVALENT SOUTHERN HEMISPHERE- 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), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension 
Bamboo US BidCo LLC

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Fluzone (Influenza Vaccine) injectable suspension, for intramuscular use 2025 Formula
Initial U.S. Approval: 1980

These highlights do not include all the information needed to use Fluzone ®Southern Hemisphere safely and effectively. See full prescribing information for Fluzone Southern Hemisphere.

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label

Influenza Vaccine

Fluzone ®

Southern Hemisphere

2025 Formula
0.5 mL Single-Dose
No Preservative
Mfd by: Sanofi Pasteur Inc.

Rx only

For IM Use

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Carton

2025

Formula

Influenza Vaccine
Fluzone ®

Southern Hemisphere

Rx only

For Intramuscular Use
For 6 months of age and older
10 single-dose prefilled syringes 0.5 mL each

sanofi

FLUZONE TRIVALENT SOUTHERN HEMISPHERE 
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), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 83703-080
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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) ANTIGEN (FORMALDEHYDE INACTIVATED)	15 ug  in 0.5 mL
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) ANTIGEN (FORMALDEHYDE INACTIVATED)	15 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 ANTIGEN (FORMALDEHYDE INACTIVATED)	15 ug  in 0.5 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83703-080-50	10 in 1 PACKAGE
1	NDC: 83703-080-88	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	03/06/2025

Labeler - Bamboo US BidCo LLC (119087615)

Revised: 6/2025

Document Id: 37f1a8d4-30e8-faa5-e063-6294a90a6650

53404-0

Set id: 37f1a8cb-1d95-0ed1-e063-6294a90a631d

Version: 1

Effective Time: 20250619