Vaccine Information: Flublok Quadrivalent Northern Hemisphere (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label

7745

NDC 49281-721-88

Influenza Vaccine
FLUBLOK® Quadrivalent
2021/2022 Formula

No Preservative

Single-Dose (0.5 mL)
For Intramuscular Injection Mfd by: Protein Sciences Corp.

Rx only

FLUBLOK® Quadrivalent/NDC 49281-721-88

PULL

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton

NDC 49281-721-10

Influenza Vaccine
FLUBLOK® Quadrivalent

2021 / 2022 Formula

10 Single-Dose
Prefilled Syringes0.5 mL each

For 18 Years of Age and Older

For Intramuscular Administration Only

SANOFI PASTEUR

Rx only

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Label — CP-1924

Lot:

Exp.:

NDC 49281-721-88

Influenza Vaccine
FLUBLOK® Quadrivalent
2021/2022 Formula
No Preservative

Single-Dose (0.5 mL)
For Intramuscular Injection
Mfd by: Protein Sciences Corp.

Rx only

CP-1924

FLUBLOK® QuadrivalentNDC 49281-721-88

PULL

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Label -- CP-1924
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Syringe Carton — CP-1923

NDC 49281-721-10

Influenza Vaccine
FLUBLOK® Quadrivalent

2021 / 2022 Formula

10 Single-Dose
Prefilled Syringes0.5 mL each

For 18 Years of Age and Older

For Intramuscular Administration Only

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 0.5 mL Syringe Carton -- CP-1923
(click image for full-size original)
FLUBLOK QUADRIVALENT NORTHERN HEMISPHERE influenza a virus a/wisconsin/588/2019 (h1n1) recombinant hemagglutinin antigen, influenza a virus a/tasmania/503/2020 (h3n2) recombinant hemagglutinin antigen, influenza b virus b/washington/02/2019 recombinant hemagglutinin antigen, and influenza b virus b/phuket/3073/2013 recombinant hemagglutinin antigen injection
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-721
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA B VIRUS B/WASHINGTON/02/2019 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN (INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN) INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN 45 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE
SODIUM CHLORIDE
POLYSORBATE 20
OCTOXYNOL-9
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-721-10 10 SYRINGE in 1 CARTON contains a SYRINGE (49281-721-88)
1 NDC:49281-721-88 0.5 mL in 1 SYRINGE This package is contained within the CARTON (49281-721-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125285 07/02/2021 06/30/2022
Labeler — Sanofi Pasteur Inc. (086723285)

Revised: 07/2021 Sanofi Pasteur Inc.

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