Vaccine Information: FLUZONE High-Dose Quadrivalent Northern Hemisphere (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.7 mL Syringe Label

NDC 49281-120-88

0.7 mL Single-Dose
Influenza Vaccine
Fluzone^® High-Dose
Quadrivalent
2020-2021 Formula
For 65 yrs of age and older
Mfd by: Sanofi Pasteur Inc.

IM only Rx only

PRINCIPAL DISPLAY PANEL — 0.7 mL Syringe Package

NDC 49281-120-65
2020-2021 Formula

For Intramuscular
Injection Only

10 Single-Dose
Prefilled Syringes
0.7 mL each

Rx only

Influenza Vaccine
Fluzone^® High-Dose
Quadrivalent

FOR ADULTS 65⁺

SANOFI PASTEUR

FLUZONE HIGH-DOSE QUADRIVALENT NORTHERN HEMISPHERE influenza a virus a/guangdong-maonan/swl1536/2019 cnic-1909 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/hong kong/2671/2019 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/washington/02/2019 antigen (formaldehyde inactivated) injection, suspension

Product Information Product Type VACCINE Item Code (Source) NDC:49281-120 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug in 0.7 mL INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug in 0.7 mL INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug in 0.7 mL INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED) (INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 60 ug in 0.7 mL

Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS Water OCTOXYNOL-9 FORMALDEHYDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:49281-120-65 10 SYRINGE, GLASS in 1 PACKAGE contains a SYRINGE, GLASS (49281-120-88) 1 NDC:49281-120-88 0.7 mL in 1 SYRINGE, GLASS This package is contained within the PACKAGE (49281-120-65)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103914 07/02/2020 06/30/2021

Labeler — Sanofi Pasteur Inc. (086723285)

Establishment
Name	Address	ID/FEI	Operations
Sanofi Pasteur Inc.		086723285	MANUFACTURE (49281-120)

Revised: 02/2021 Sanofi Pasteur Inc.