NDC 49281-719

Flublok Quadrivalent

Influenza 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

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/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; Influenza B Virus B/maryland/15/2016 Recombinant Hemagglutinin Antigen.

• Product ID: 49281-719_57fc7a7f-806c-43b1-9028-266476af00bc
• NDC: 49281-719
• Product Type: Vaccine
• Proprietary Name: Flublok Quadrivalent
• Generic Name: Influenza 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
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2019-07-01
• Marketing Category: BLA / BLA
• Application Number: BLA125285
• Labeler Name: Sanofi Pasteur Inc.
• Substance Name: INFLUENZA 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; INFLUENZA B VIRUS B/MARYLAND/15/2016 RECOMBINANT HEMAGGLUTININ ANTIGEN
• Active Ingredient Strength: 45 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 49281-719-10

10 SYRINGE in 1 CARTON (49281-719-10) > .5 mL in 1 SYRINGE (49281-719-88)

• Marketing Start Date: 2019-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49281-719-10 [49281071910]

Flublok Quadrivalent INJECTION

• Marketing Category: BLA
• Application Number: BLA125285
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2019-07-01

NDC 49281-719-88 [49281071988]

Flublok Quadrivalent INJECTION

• Marketing Category: BLA
• Application Number: BLA125285
• Product Type: VACCINE
• Billing Unit: ML
• Marketing Start Date: 2019-07-01

Drug Details

Active Ingredients

Ingredient	Strength
INFLUENZA A VIRUS A/BRISBANE/02/2018 (H1N1) RECOMBINANT HEMAGGLUTININ ANTIGEN	45 ug/.5mL

NDC Crossover Matching brand name "Flublok Quadrivalent" or generic name "Influenza 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"

NDC	Brand Name	Generic Name
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
49281-719	Flublok Quadrivalent	INFLUENZA 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