NDC 58160-887

FLUARIX QUADRIVALENT 2021/2022

Influenza Virus Vaccine

FLUARIX QUADRIVALENT 2021/2022 is a Intramuscular Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/tasmania/503/2020 Ivr-221 (h3n2) Antigen (formaldehyde Inactivated); Influenza B Virus B/washington/02/2019 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated).

Product ID58160-887_eea6e717-9fe9-48cb-848d-2685fe8f0970
NDC58160-887
Product TypeVaccine
Proprietary NameFLUARIX QUADRIVALENT 2021/2022
Generic NameInfluenza Virus Vaccine
Dosage FormSuspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2021-07-02
Marketing End Date2022-06-30
Marketing CategoryBLA /
Application NumberBLA125127
Labeler NameGlaxoSmithKline Biologicals SA
Substance NameINFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient Strength15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
NDC Exclude FlagN

Packaging

NDC 58160-887-52

10 SYRINGE in 1 CARTON (58160-887-52) > .5 mL in 1 SYRINGE (58160-887-41)
Marketing Start Date2021-07-02
Marketing End Date2022-06-30
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "FLUARIX QUADRIVALENT 2021/2022" or generic name "Influenza Virus Vaccine"

NDCBrand NameGeneric Name
58160-885FLUARIX QUADRIVALENTinfluenza virus vaccine
58160-887FLUARIX QUADRIVALENTinfluenza virus vaccine
58160-890FLUARIX QUADRIVALENTinfluenza virus vaccine
58160-896FLUARIX QUADRIVALENTinfluenza virus vaccine
58160-898FLUARIX QUADRIVALENTinfluenza virus vaccine
19515-808Flulaval Quadrivalentinfluenza virus vaccine
19515-816Flulaval Quadrivalentinfluenza virus vaccine
19515-818Flulaval Quadrivalentinfluenza virus vaccine
19515-897Flulaval Quadrivalentinfluenza virus vaccine
19515-900Flulaval Quadrivalentinfluenza virus vaccine
19515-906Flulaval Quadrivalentinfluenza virus vaccine
19515-909Flulaval Quadrivalentinfluenza virus vaccine

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