NDC 70461-322
Flucelvax Quadrivalent
Influenza A Virus A/delaware/55/2019 Cvr-45 (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, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)
Flucelvax Quadrivalent is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus Inc.. The primary component is Influenza A Virus A/darwin/11/2021 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated); Influenza A Virus A/delaware/55/2019 Cvr-45 (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).
| Product ID | 70461-322_86fb1dd8-fc0c-4b78-95fe-80cd854a9874 |
| NDC | 70461-322 |
| Product Type | Vaccine |
| Proprietary Name | Flucelvax Quadrivalent |
| Generic Name | Influenza A Virus A/delaware/55/2019 Cvr-45 (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, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2022-07-01 |
| Marketing End Date | 2023-07-31 |
| Marketing Category | BLA / |
| Application Number | BLA125408 |
| Labeler Name | Seqirus Inc. |
| Substance Name | INFLUENZA A VIRUS A/DARWIN/11/2021 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/DELAWARE/55/2019 CVR-45 (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) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
Packaging
NDC 70461-322-03
10 SYRINGE, GLASS in 1 CARTON (70461-322-03) > .5 mL in 1 SYRINGE, GLASS (70461-322-04)
| Marketing Start Date | 2022-07-01 |
| Marketing End Date | 2023-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "Flucelvax Quadrivalent" or generic name "Influenza A Virus A/delaware/55/2019 Cvr-45 (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, Propiolactone Inactivated), Influenza B Virus B/singapore/inftt-16-0610/2016 Antigen (mdck Cell Derived, Propiolactone Inactivated)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70461-319 | FLUCELVAX QUADRIVALENT | INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED, INFLUENZA A VIRUS A/INDIANA/08/2018 (H3N2) 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/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-320 | FLUCELVAX QUADRIVALENT | INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) 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/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-321 | FLUCELVAX QUADRIVALENT | INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-322 | Flucelvax Quadrivalent | INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (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, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-419 | FLUCELVAX QUADRIVALENT | INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED, INFLUENZA A VIRUS A/INDIANA/08/2018 (H3N2) 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/IOWA/06/2017 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-420 | FLUCELVAX QUADRIVALENT | INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) 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/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-421 | FLUCELVAX QUADRIVALENT | INFLUENZA A VIRUS A/WASHINGTON/19/2020 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-422 | Flucelvax Quadrivalent | INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (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, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Singapore/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Trademark Results [Flucelvax Quadrivalent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLUCELVAX QUADRIVALENT 79170996 4938921 Live/Registered |
Seqirus UK Limited 2015-07-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.