NDC 58160-890
FLUARIX QUADRIVALENT 2022/2023
Influenza Virus Vaccine
FLUARIX QUADRIVALENT 2022/2023 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/darwin/6/2021 Ivr-227 (h3n2) Antigen (formaldehyde Inactivated); Influenza A Virus A/victoria/2570/2019 Ivr-215 (h1n1) Antigen (formaldehyde Inactivated); Influenza B Virus B/austria/1359417/2021 Bvr-26 Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated).
| Product ID | 58160-890_67f452dd-8375-484b-b848-633e58881ddf |
| NDC | 58160-890 |
| Product Type | Vaccine |
| Proprietary Name | FLUARIX QUADRIVALENT 2022/2023 |
| Generic Name | Influenza Virus Vaccine |
| Dosage Form | Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2022-07-01 |
| Marketing Category | BLA / |
| Application Number | BLA125127 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | INFLUENZA A VIRUS A/DARWIN/6/2021 IVR-227 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 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 |
| Listing Certified Through | 2023-12-31 |