NDC 49281-721

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

Flublok Quadrivalent Northern Hemisphere is a Intramuscular Injection in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is 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; Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen.

Product ID49281-721_638284a4-c749-45cf-b72b-0b586ba4a8e9
NDC49281-721
Product TypeVaccine
Proprietary NameFlublok Quadrivalent Northern Hemisphere
Generic NameInfluenza 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
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2021-07-02
Marketing End Date2022-06-30
Marketing CategoryBLA /
Application NumberBLA125285
Labeler NameSanofi Pasteur Inc.
Substance NameINFLUENZA 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; INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN
Active Ingredient Strength45 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC Exclude FlagN

Packaging

NDC 49281-721-10

10 SYRINGE in 1 CARTON (49281-721-10) > .5 mL in 1 SYRINGE (49281-721-88)
Marketing Start Date2021-07-02
Marketing End Date2022-06-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Flublok Quadrivalent Northern Hemisphere" or generic name "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"

NDCBrand NameGeneric Name
49281-720Flublok Quadrivalent Northern HemisphereINFLUENZA A VIRUS A/HAWAII/70/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/MINNESOTA/41/2019 (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
49281-721Flublok Quadrivalent Northern HemisphereINFLUENZA 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
49281-722Flublok Quadrivalent Northern HemisphereINFLUENZA A VIRUS A/WISCONSIN/588/2019 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/DARWIN/6/2021 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.