NDC 58160-896
FLUARIX QUADRIVALENT 2019/2020
Influenza Virus Vaccine
FLUARIX QUADRIVALENT 2019/2020 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/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); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated).
| Product ID | 58160-896_242326af-efc3-45bd-9b15-c079dfac491c |
| NDC | 58160-896 |
| Product Type | Vaccine |
| Proprietary Name | FLUARIX QUADRIVALENT 2019/2020 |
| Generic Name | Influenza Virus Vaccine |
| Dosage Form | Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2019-07-02 |
| Marketing End Date | 2020-06-30 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125127 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | INFLUENZA 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); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |