NDC 49281-339

FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE

Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated)

FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated).

• Product ID: 49281-339_3f5599a4-c790-49bd-a4fc-7846d22f3055
• NDC: 49281-339
• Product Type: Vaccine
• Proprietary Name: FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE
• Generic Name: Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated)
• Dosage Form: Injection, Suspension
• Route of Administration: INTRAMUSCULAR
• Marketing Start Date: 2022-02-15
• Marketing End Date: 2022-12-31
• Marketing Category: BLA /
• Application Number: BLA103914
• Labeler Name: Sanofi Pasteur Inc.
• Substance Name: INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
• Active Ingredient Strength: 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
• NDC Exclude Flag: N

Packaging

NDC 49281-339-15

1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-339-15) > 5 mL in 1 VIAL, MULTI-DOSE (49281-339-78)

• Marketing Start Date: 2022-02-15
• Marketing End Date: 2022-12-31
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

NDC Crossover Matching brand name "FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE" or generic name "Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated), And Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated)"

NDC	Brand Name	Generic Name
49281-181	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (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)
49281-182	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Hong Kong/2671/2019 IVR-208 (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)
49281-320	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (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)
49281-321	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Hong Kong/2671/2019 IVR-208 (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)
49281-322	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)
49281-336	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SOUTH AUSTRALIA/34/2019 IVR-197 (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)
49281-337	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Hong Kong/2671/2019 IVR-208 (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)
49281-339	FLUZONE QUADRIVALENT SOUTHERN HEMISPHERE	INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)