"58160-909-52" National Drug Code (NDC)

Fluarix Quadrivalent 10 SYRINGE in 1 CARTON (58160-909-52) / .5 mL in 1 SYRINGE (58160-909-41)
(GlaxoSmithKline Biologicals SA)

NDC Code58160-909-52
Package Description10 SYRINGE in 1 CARTON (58160-909-52) / .5 mL in 1 SYRINGE (58160-909-41)
Product NDC58160-909
Product Type NameVACCINE
Proprietary NameFluarix Quadrivalent
Proprietary Name Suffix2023/2024
Non-Proprietary NameInfluenza Virus Vaccine
Dosage FormSUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20230630
End Marketing Date20240630
Marketing Category NameBLA
Application NumberBLA125127
ManufacturerGlaxoSmithKline Biologicals SA
Substance NameINFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength15; 15; 15; 15
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL

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