NDC 49281-718

Flublok Quadrivalent

Influenza A Virus A/michigan/45/2015 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/singapore/infimh-16-0019/2016 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen

Flublok Quadrivalent 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/michigan/45/2015 (h1n1) Recombinant Hemagglutinin Antigen; Influenza A Virus A/singapore/infimh-16-0019/2016 (h3n2) Recombinant Hemagglutinin Antigen; Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen; Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen.

Product ID49281-718_53a8b76c-77bb-4506-bb65-860b73b1af3c
NDC49281-718
Product TypeVaccine
Proprietary NameFlublok Quadrivalent
Generic NameInfluenza A Virus A/michigan/45/2015 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/singapore/infimh-16-0019/2016 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2018-06-29
Marketing End Date2019-06-30
Marketing CategoryBLA / BLA
Application NumberBLA125285
Labeler NameSanofi Pasteur Inc.
Substance NameINFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN; INFLUENZA B VIRUS B/MARYLAND/15/2016 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 49281-718-10

10 SYRINGE in 1 CARTON (49281-718-10) > .5 mL in 1 SYRINGE (49281-718-88)
Marketing Start Date2018-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49281-718-10 [49281071810]

Flublok Quadrivalent INJECTION
Marketing CategoryBLA
Application NumberBLA125285
Product TypeVACCINE
Billing UnitML
Marketing Start Date2018-06-29
Marketing End Date2019-06-30

NDC 49281-718-88 [49281071888]

Flublok Quadrivalent INJECTION
Marketing CategoryBLA
Application NumberBLA125285
Product TypeVACCINE
Billing UnitML
Marketing Start Date2018-06-29
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
INFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN45 ug/.5mL

NDC Crossover Matching brand name "Flublok Quadrivalent" or generic name "Influenza A Virus A/michigan/45/2015 (h1n1) Recombinant Hemagglutinin Antigen, Influenza A Virus A/singapore/infimh-16-0019/2016 (h3n2) Recombinant Hemagglutinin Antigen, Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen, And Influenza B Virus B/phuket/3073/2013 Recombinant Hemagglutinin Antigen"

NDCBrand NameGeneric Name
49281-718Flublok QuadrivalentINFLUENZA A VIRUS A/MICHIGAN/45/2015 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/Singapore/INFIMH-16-0019/2016 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/Maryland/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN
49281-719Flublok QuadrivalentINFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) RECOMBINANT HEMAGGLUTININ ANTIGEN, INFLUENZA B VIRUS B/PHUKET/3073/2013 RECOMBINANT HEMAGGLUTININ ANTIGEN, and INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN

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