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

FLUZONE QUADRIVALENT NORTHERN HEMISPHERE by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 - 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

INGREDIENTS AND APPEARANCE

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 Type	VACCINE	Item Code (Source)	NDC: 83703-044
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Name	Strength
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
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: 83703-044-50	10 in 1 PACKAGE
1	NDC: 83703-044-88	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	07/01/2022

Labeler - Bamboo US BidCo LLC (119087615)