FLUARIX
- Product NDC
- 58160-912
- 11-digit product format
- 581600912
- Labeler code
- 58160
- Product ID
- 58160-912_924e4aa4-fda4-449f-8427-6c964b661ccc
- Type
- VACCINE
- Nonproprietary name
- influenza virus vaccine
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- GlaxoSmithKline Biologicals SA
- Application
- BLA125127
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- Marketing end
- 2026-06-30
- Substance
- INFLUENZA A VIRUS A/THAILAND/8/2022 IVR-237 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58160-912-41 | FLUARIX2025/2026 | 0.5 mL in 1 SYRINGE | SUSPENSION | 0.5 | | 16 |
| 58160-912-52 | FLUARIX2025/2026 | 10 in 1 CARTON | SUSPENSION | 10 | | 16 |
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 |
|---|
| 58160-912-41 | 58160091241 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | | Historical |
| 58160-912-52 | 58160091252 | 10 SYRINGE in 1 CARTON (58160-912-52) / .5 mL in 1 SYRINGE (58160-912-41) | 10 syringe | 2025-07-01 | 2026-06-30 | No | No | Historical |