"49281-405-65" National Drug Code (NDC)

Fluzone High-dose 10 SYRINGE, GLASS in 1 PACKAGE (49281-405-65) / .5 mL in 1 SYRINGE, GLASS (49281-405-88)
(Sanofi Pasteur Inc.)

NDC Code49281-405-65
Package Description10 SYRINGE, GLASS in 1 PACKAGE (49281-405-65) / .5 mL in 1 SYRINGE, GLASS (49281-405-88)
Product NDC49281-405
Product Type NameVACCINE
Proprietary NameFluzone High-dose
Non-Proprietary NameInfluenza A Virus A/michigan/45/2015 X-275 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/maryland/15/2016 Bx-69a (a B/colorado/6/2017-like Virus) Antigen (formaldehyde Inactivated)
Dosage FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20190701
Marketing Category NameBLA
Application NumberBLA103914
ManufacturerSanofi Pasteur Inc.
Substance NameINFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength60; 60; 60
Strength Unitug/.5mL; ug/.5mL; ug/.5mL

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