FLUARIX 2026/2027
- Product NDC
- 58160-725
- 11-digit product format
- 581600725
- Labeler code
- 58160
- Product ID
- 58160-725_2d728e3c-d550-47fb-8fa9-3ce0f244512b
- Type
- VACCINE
- Nonproprietary name
- influenza virus vaccine
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Application
- BLA125127
- Marketing category
- BLA
- Marketing start
- 2026-07-01
- Marketing end
- 2027-06-30
- Substance
- INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 15 ug/.5mL
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUARIX
- Brand name suffix
- 2026/2027
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
DailyMed Product Concepts#
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 | Status |
|---|
| 58160-725-52 | 58160072552 | 10 SYRINGE in 1 CARTON (58160-725-52) / .5 mL in 1 SYRINGE (58160-725-41) | 10 syringe | 2026-07-01 | 2027-06-30 | 0 | Historical |