FLUARIX QUADRIVALENT
- Product NDC
- 58160-887
- 11-digit product format
- 581600887
- Labeler code
- 58160
- Product ID
- 58160-887_eea6e717-9fe9-48cb-848d-2685fe8f0970
- Type
- VACCINE
- Nonproprietary name
- influenza virus vaccine
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125127
- Marketing category
- BLA
- Marketing start
- 2021-07-02
- Marketing end
- 2022-06-30
- Substance
- INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 58160-887 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 58160-887 | 58160-887-52 | D | Discontinued by firm | | 2026-07-31 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125127 | Fluarix, Fluarix Quadrivalent | Influenza Vaccine | 351(a) | Rx | 2026-06-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58160-887-52 | 58160088752 | 10 SYRINGE in 1 CARTON (58160-887-52) > .5 mL in 1 SYRINGE (58160-887-41) | 10 syringe | 2021-07-02 | 2022-06-30 | No | No | Current |