NDC 70461-319
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)
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)
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) 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/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).
| Product ID | 70461-319_553a8904-184d-4910-8ba3-f0dd5d8fb5d1 |
| NDC | 70461-319 |
| Product Type | Vaccine |
| Proprietary Name | FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) |
| Generic Name | 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) |
| Dosage Form | Injection, Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2016-05-23 |
| Marketing End Date | 2020-07-31 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125408 |
| Labeler Name | Seqirus, Inc. |
| Substance Name | 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) |
| Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL |
| NDC Exclude Flag | N |
Packaging
NDC 70461-319-03
10 SYRINGE, GLASS in 1 CARTON (70461-319-03) > .5 mL in 1 SYRINGE, GLASS (70461-319-04)
| Marketing Start Date | 2016-05-23 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 70461-319-03 [70461031903]
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125408 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-05-23 |
| Marketing End Date | 2020-07-31 |
NDC 70461-319-04 [70461031904]
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) INJECTION, SUSPENSION
| Marketing Category | BLA |
| Application Number | BLA125408 |
| Product Type | VACCINE |
| Billing Unit | ML |
| Marketing Start Date | 2016-05-23 |
| Marketing End Date | 2020-07-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/IDAHO/07/2018 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED | 15 ug/.5mL |
NDC Crossover Matching brand name "FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)" or generic name "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)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70461-318 | FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) | 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) |
| 70461-319 | 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) |
| 70461-419 | 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) |
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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