FLUZONE TRIVALENT 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 
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Fluzone (Influenza Vaccine)
injectable suspension, for intramuscular use
2025–2026 Formula
Initial U.S. Approval: 1980

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label

Influenza Vaccine

Fluzone ®
Rx only

2025-2026 Formula

No Preservative
For IM Use

0.5 mL Single-Dose

Mfd by: Sanofi Pasteur Inc.

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package

2025-2026

Formula

Influenza Vaccine
Fluzone ®

Rx only

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

sanofi

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package

FLUZONE TRIVALENT 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 TypeVACCINEItem Code (Source)NDC:83703-083
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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)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) HEMAGGLUTININ 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 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
WATER (UNII: 059QF0KO0R)  
FORMALDEHYDE (UNII: 1HG84L3525)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83703-083-5010 in 1 PACKAGE
1NDC:83703-083-880.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA10391407/01/202406/30/2026
Labeler - Bamboo US BidCo LLC (119087615)

Revised: 6/2026
Document Id: 53ea41a0-12ec-1b29-e063-6394a90ab79f
Set id: 49dd5fdf-532e-aa5c-e063-6394a90a6cfc
Version: 2
Effective Time: 20260610
 
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