Flucelvax
- Product NDC
- 85766-263
- 11-digit product format
- 857660263
- Labeler code
- 85766
- Product ID
- 85766-263_5a564edc-8375-1611-e063-6294a90a0b80
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Tasmania/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Tasmania/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Arizona/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Application
- BLA125408
- Marketing category
- BLA
- Marketing start
- 2026-07-01
- Marketing end
- 2027-07-31
- Substance
- INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
- Active strength
- 15 ug/.5mL
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flucelvax
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | Disc | 2026-08-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 85766-263-10 | 85766026310 | 10 SYRINGE, GLASS in 1 CARTON (85766-263-10) / .5 mL in 1 SYRINGE, GLASS (85766-263-01) | 2026-07-01 | 2027-07-31 | 0 | Historical |