FLUAD
- Product NDC
- 70461-025
- 11-digit product format
- 704610025
- Labeler code
- 70461
- Product ID
- 70461-025_0677b781-d088-4d71-ba38-765049878fbb
- Type
- VACCINE
- Nonproprietary name
- 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)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Seqirus, Inc.
- Application
- BLA125510
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- Marketing end
- 2026-07-31
- Substance
- INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUAD
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (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 |
|---|
| 70461-025-03 | FLUAD | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 13 |
| 70461-025-04 | FLUAD | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SUSPENSION | 0.5 | | 13 |
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 |
|---|
| 70461-025-03 | 70461002503 | 10 SYRINGE, GLASS in 1 CARTON (70461-025-03) / .5 mL in 1 SYRINGE, GLASS (70461-025-04) | | 2025-07-01 | 2026-07-31 | No | No | Historical |
| 70461-025-04 | 70461002504 | 0.5 mL in 1 SYRINGE, GLASS | 0.5 ml | | | | | Historical |