NDC 58160-885
FLUARIX QUADRIVALENT 2020/2021
Influenza Virus Vaccine
FLUARIX QUADRIVALENT 2020/2021 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/guangdong-maonan/swl1536/2019 Cnic-1909 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/hong Kong/2671/2019 Nib-121 (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 | 58160-885_797e9f6a-d957-4f20-8fac-5f1ac8b1de31 |
| NDC | 58160-885 |
| Product Type | Vaccine |
| Proprietary Name | FLUARIX QUADRIVALENT 2020/2021 |
| Generic Name | Influenza Virus Vaccine |
| Dosage Form | Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2020-07-02 |
| Marketing End Date | 2021-06-30 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125127 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 NIB-121 (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 |