"49281-379-50" National Drug Code (NDC)

Fluzone High-dose Quadrivalent Southern Hemisphere 10 SYRINGE, GLASS in 1 PACKAGE (49281-379-50) / .7 mL in 1 SYRINGE, GLASS (49281-379-88)
(Sanofi Pasteur Inc.)

NDC Code49281-379-50
Package Description10 SYRINGE, GLASS in 1 PACKAGE (49281-379-50) / .7 mL in 1 SYRINGE, GLASS (49281-379-88)
Product NDC49281-379
Product Type NameVACCINE
Proprietary NameFluzone High-dose Quadrivalent Southern Hemisphere
Non-Proprietary NameInfluenza A Virus A/sydney/5/2021 San-013 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/darwin/9/2021 San-010 (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)
Dosage FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20230213
End Marketing Date20231231
Marketing Category NameBLA
Application NumberBLA103914
ManufacturerSanofi Pasteur Inc.
Substance NameINFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SYDNEY/5/2021 SAN-013 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength60; 60; 60; 60
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL

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