| NDC Code | 70461-423-10 |
| Package Description | 1 VIAL, MULTI-DOSE in 1 CARTON (70461-423-10) / 5 mL in 1 VIAL, MULTI-DOSE (70461-423-11) |
| Product NDC | 70461-423 |
| Product Type Name | VACCINE |
| Proprietary Name | Flucelvax Quadrivalent |
| Non-Proprietary Name | Influenza A Virus A/georgia/12/2022 Crv-167 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated),influenza B Virus B/singapore/wuh4618/2021 Antigen (mdck Cell Derived, Ropiolactone Inactivated),influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated) |
| Dosage Form | INJECTION, SUSPENSION |
| Usage | INTRAMUSCULAR |
| Start Marketing Date | 20230701 |
| End Marketing Date | 20240731 |
| Marketing Category Name | BLA |
| Application Number | BLA125408 |
| Manufacturer | Seqirus Inc. |
| Substance Name | INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| Strength | 15; 15; 15; 15 |
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |