Flucelvax
- Product NDC
- 70461-555
- 11-digit product format
- 704610555
- Labeler code
- 70461
- Product ID
- 70461-555_9c8fddaf-707b-4bc0-9518-98bdf37e4fc9
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Georgia/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Victoria/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED),INFLUENZA B VIRUS B/Singapore/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Seqirus Inc.
- Application
- BLA125408
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- Marketing end
- 2026-07-31
- Substance
- INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE 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
- Flucelvax
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/GEORGIA/12/2022 CVR-167 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/VICTORIA/800/2024 CVR-289 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS B/SINGAPORE/WUH4618/2021 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70461-555-10 | Flucelvax | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | 12 | |
| 70461-555-11 | Flucelvax | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70461-555-10 | ML - Milliliter | 70461-555 | 5ca3d1ae-ea61-4112-bb06-cd755c805e2f | 1 | 2025-08-11 |
| 70461-555-11 | ML - Milliliter | 70461-555 | 2dda21d5-4775-4869-a633-fa70c6dd783d | 1 | 2025-08-11 |
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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70461-555-10 | 70461055510 | 1 VIAL, MULTI-DOSE in 1 CARTON (70461-555-10) / 5 mL in 1 VIAL, MULTI-DOSE (70461-555-11) | 2025-07-01 | 2026-07-31 | No | No | Historical | |
| 70461-555-11 | 70461055511 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |