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"58160-900-52" National Drug Code (NDC)

Fluarix Quadrivalent 10 SYRINGE in 1 CARTON (58160-900-52) > .5 mL in 1 SYRINGE (58160-900-41)
(GlaxoSmithKline Biologicals SA)

NDC Code58160-900-52
Package Description10 SYRINGE in 1 CARTON (58160-900-52) > .5 mL in 1 SYRINGE (58160-900-41)
Product NDC58160-900
Product Type NameVACCINE
Proprietary NameFluarix Quadrivalent
Proprietary Name Suffix2013/2014
Non-Proprietary NameInfluenza Virus Vaccine
Dosage FormSUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20130701
Marketing Category NameBLA
Application NumberBLA125127
ManufacturerGlaxoSmithKline Biologicals SA
Substance NameINFLUENZA A VIRUS A/CHRISTCHURCH/16/2010 NIB-74XP (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength15; 15; 15; 15
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL

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