FLUAD
- Product NDC
- 70461-026
- 11-digit product format
- 704610026
- Labeler code
- 70461
- Product ID
- 70461-026_09bab40b-c217-4f1f-b9fd-bfeb0f8f9486
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Missouri/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Application
- BLA125510
- Marketing category
- BLA
- Marketing start
- 2026-07-01
- Marketing end
- 2027-07-31
- Substance
- INFLUENZA A VIRUS A/MISSOURI/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 15 ug/.5mL
- 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/MISSOURI/11/2025 IVR-279 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/MICHIGAN/105/2025 IVR-285 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 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 |
|---|
| 125510 | Fluad | Influenza Vaccine, Adjuvanted | 351(a) | Disc | 2026-06-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 70461-026-03 | 70461002603 | 10 SYRINGE, GLASS in 1 CARTON (70461-026-03) / .5 mL in 1 SYRINGE, GLASS (70461-026-04) | 2026-07-01 | 2027-07-31 | 0 | Historical |