FLUARIX QUADRIVALENT
- Product NDC
- 58160-885
- 11-digit product format
- 581600885
- Labeler code
- 58160
- Product ID
- 58160-885_797e9f6a-d957-4f20-8fac-5f1ac8b1de31
- Type
- VACCINE
- Nonproprietary name
- influenza virus vaccine
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125127
- Marketing category
- BLA
- Marketing start
- 2020-07-02
- Marketing end
- 2021-06-30
- Substance
- INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 NIB-121 (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
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 |
|---|
| 58160-885-52 | 58160088552 | 10 SYRINGE in 1 CARTON (58160-885-52) > .5 mL in 1 SYRINGE (58160-885-41) | 10 syringe | 2020-07-02 | 2021-06-30 | No | No | Current |