FLULAVAL
- Product NDC
- 19515-904
- 11-digit product format
- 195150904
- Labeler code
- 19515
- Product ID
- 19515-904_50e2de58-d7ab-497b-b580-075013f74185
- Type
- VACCINE
- Nonproprietary name
- influenza virus vaccine
- Dosage form
- SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- ID Biomedical Corporation of Quebec
- Application
- BLA125163
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- Marketing end
- 2026-06-30
- Substance
- INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED)
- Active strength
- 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLULAVAL
- Brand name suffix
- 2025/2026
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 19515-904-41 | FLULAVAL2025/2026 | 0.5 mL in 1 SYRINGE | SUSPENSION | 0.5 | | 15 |
| 19515-904-52 | FLULAVAL2025/2026 | 10 in 1 CARTON | SUSPENSION | 10 | | 15 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 19515-904-41 | 19515090441 | 0.5 mL in 1 SYRINGE | 0.5 ml | | | | | Historical |
| 19515-904-52 | 19515090452 | 10 SYRINGE in 1 CARTON (19515-904-52) / .5 mL in 1 SYRINGE (19515-904-41) | 10 syringe | 2025-07-01 | 2026-06-30 | No | No | Historical |