Flucelvax
- Product NDC
- 70461-656
- 11-digit product format
- 704610656
- Labeler code
- 70461
- Product ID
- 70461-656_507ef735-5913-4f01-831b-c53285db8f64
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flucelvax
Active Ingredients#
| 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 |
DailyMed Product Concepts#
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125408 | Flucelvax, Flucelvax Quadrivalent | Influenza Vaccine | 351(a) | Disc | 2026-06-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2718382 | FLUCELVAX 2025-2026 vaccine 0.5 ML Prefilled Syringe | PSN | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718374 | FLUCELVAX 2025-2026 vaccine Injectable Suspension | PSN | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718378 | influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled Syringe | PSN | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718368 | influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) Injectable Suspension | PSN | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718382 | 0.5 ML influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Prefilled Syringe [Flucelvax 2025-2026] | SBD | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718374 | influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension [Flucelvax 2025-2026] | SBD | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718378 | 0.5 ML influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Prefilled Syringe | SCD | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718368 | influenza A virus A/Georgia/12/2022 (H1N1) antigen 0.03 MG/ML / influenza A virus A/Victoria/800/2024 (H3N2) antigen 0.03 MG/ML / influenza B virus B/Singapore/WUH4618/2021 antigen 0.03 MG/ML Injectable Suspension | SCD | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718382 | Flucelvax 2025-2026 vaccine 0.5 ML Prefilled Syringe | SY | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718374 | Flucelvax 2025-2026 vaccine Injectable Suspension | SY | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718378 | influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) 0.5 ML Prefilled Syringe | SY | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
| 2718368 | influenza virus vaccine 2025-2026 (trivalent - Georgia/Victoria/Singapore) Injectable Suspension | SY | 3513dfb0-4d62-4ad1-bb15-75c7555896ff | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|---|
| 70461-656-03 | 70461065603 | 10 SYRINGE, GLASS in 1 CARTON (70461-656-03) / .5 mL in 1 SYRINGE, GLASS (70461-656-04) | 2026-07-01 | 2027-07-31 | 0 | Historical |