NDC 58160-898
FLUARIX QUADRIVALENT 2018/2019
Influenza Virus Vaccine
FLUARIX QUADRIVALENT 2018/2019 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/singapore/gp1908/2015 Ivr-180 (h1n1) Antigen (formaldehyde Inactivated); Influenza A Virus A/singapore/infimh-16-0019/2016 Nib-104 (h3n2) Antigen (formaldehyde Inactivated); Influenza B Virus B/maryland/15/2016 Bx-69a Antigen (formaldehyde Inactivated); Influenza B Virus B/phuket/3073/2013 Antigen (formaldehyde Inactivated).
| Product ID | 58160-898_5db26e22-e3ea-45df-9ab5-64073c20b012 |
| NDC | 58160-898 |
| Product Type | Vaccine |
| Proprietary Name | FLUARIX QUADRIVALENT 2018/2019 |
| Generic Name | Influenza Virus Vaccine |
| Dosage Form | Suspension |
| Route of Administration | INTRAMUSCULAR |
| Marketing Start Date | 2018-06-29 |
| Marketing End Date | 2019-06-30 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125127 |
| Labeler Name | GlaxoSmithKline Biologicals SA |
| Substance Name | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A 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 |