FLUZONE QUADRIVALENT NORTHERN HEMISPHERE- influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (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) injection, suspension 
Bamboo US BidCo LLC

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

Fluzone Quadrivalent (Influenza Vaccine)
Suspension for Intramuscular Injection
2023-2024 Formula
Initial U.S. Approval (Fluzone Quadrivalent): 2013

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package

2022 – 2023 Formula

10 Single-Dose
Prefilled Syringes
0.5 mL each

Rx only

4
STRAINS

Influenza Vaccine
Fluzone ®Quadrivalent

For 6 months of age and older
For intramuscular injection only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Package - 49281-422-50

PRINCIPAL DISPLAY PANEL - 10 Syringe Package

2022 – 2023 Formula

10 Single-Dose
Prefilled Syringes
0.5 mL each

Rx only

4
STRAINS

Influenza Vaccine
Fluzone ®Quadrivalent

For 6 months of age and older
For intramuscular injection only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL - 10 Syringe Package - 49281-422-50

FLUZONE QUADRIVALENT NORTHERN HEMISPHERE 
influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (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) injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:83703-044
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: WD5E5VYM2E) (INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:ERB9SJ9VMQ) INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: KJA387FHB2) (INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:6S4Y8A8UEY) INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: B93BQX9789) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:9HB0XUS9TM) INFLUENZA B VIRUS B/PHUKET/3073/2013 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:83703-044-5010 in 1 PACKAGE
1NDC:83703-044-880.5 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
BLABLA10391407/01/2022
Labeler - Bamboo US BidCo LLC (119087615)

Revised: 6/2024
Document Id: 1adca833-490e-de00-e063-6294a90a6f9c
Set id: 1adcb911-4e6b-7b6f-e063-6394a90a8264
Version: 1
Effective Time: 20240614
 
Bamboo US BidCo LLC