"49281-331-15" National Drug Code (NDC)

Fluzone Quadrivalent Southern Hemisphere 1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-331-15) > 5 mL in 1 VIAL, MULTI-DOSE (49281-331-78)
(Sanofi Pasteur Inc.)

NDC Code49281-331-15
Package Description1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-331-15) > 5 mL in 1 VIAL, MULTI-DOSE (49281-331-78)
Product NDC49281-331
Product Type NameVACCINE
Proprietary NameFluzone Quadrivalent Southern Hemisphere
Non-Proprietary NameInfluenza A Virus A/california/7/2009 X-179a (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/hong Kong/4801/2014 X-263b (h3n2) Antigen (formaldehyde Inactivated), Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated), And Influenza B Virus B/brisbane/60/2008 Antigen (formaldehyde Inactivated)
Dosage FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20160324
End Marketing Date20161231
Marketing Category NameBLA
Application NumberBLA103914
ManufacturerSanofi Pasteur Inc.
Substance NameINFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength15; 15; 15; 15
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL

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