NDC 70461-420
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL)
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)
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) 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/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).
| Product ID | 70461-420_3337b637-b72f-4b9c-9b36-dd4b718637ba |
| NDC | 70461-420 |
| Product Type | Vaccine |
| Proprietary Name | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) |
| Generic Name | 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) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2020-07-02 |
| Marketing End Date | 2021-07-31 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125408 |
| Labeler Name | Seqirus Inc. |
| Substance Name | 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) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
Packaging
NDC 70461-420-10
1 VIAL, MULTI-DOSE in 1 CARTON (70461-420-10) > 5 mL in 1 VIAL, MULTI-DOSE (70461-420-11)
| Marketing Start Date | 2020-07-02 |
| Marketing End Date | 2021-07-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL)" or generic name "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)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70461-418 | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/NORTH CAROLINA/04/2016 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/IOWA/06/2017 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
| 70461-419 | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) | FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) |
| 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) |
| 70461-420 | 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) |
Trademark Results [FLUCELVAX QUADRIVALENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLUCELVAX QUADRIVALENT 79170996 4938921 Live/Registered |
Seqirus UK Limited 2015-07-06 |
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