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 ID | 58160-887_eea6e717-9fe9-48cb-848d-2685fe8f0970 |
| NDC | 58160-887 |
| Product Type | Vaccine |
| Proprietary Name | FLUARIX QUADRIVALENT 2021/2022 |
| Generic Name | Influenza Virus Vaccine |
| Dosage Form | Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2021-07-02 |
| Marketing End Date | 2022-06-30 |
| Marketing Category | BLA / |
| Application Number | BLA125127 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | 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) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |