FLUZONE TRIVALENT NORTHERN HEMISPHERE
- Product NDC
- 49281-643
- 11-digit product format
- 492810643
- Labeler code
- 49281
- Product ID
- 49281-643_499121a9-d080-4783-8654-940b8a83456f
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136/RV/2023 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Sanofi Vaccines US Inc.
- Application
- BLA103914
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- Marketing end
- 2026-06-30
- 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/MICHIGAN/01/2021 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
- FLUZONE TRIVALENT NORTHERN HEMISPHERE
Active Ingredients#
| 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/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49281-643-15 | FLUZONE TRIVALENT NORTHERN HEMISPHERE | 1 in 1 PACKAGE | INJECTION, SUSPENSION | 1 | 12 | |
| 49281-643-78 | FLUZONE TRIVALENT NORTHERN HEMISPHERE | 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 |
|---|---|---|---|---|---|
| 49281-643-15 | ML - Milliliter | 49281-643 | 4af441e9-4eb7-4d53-b2de-8b972f098ce5 | 1 | 2025-08-11 |
| 49281-643-78 | ML - Milliliter | 49281-643 | c22b1938-0a75-4af8-b177-845dc16d0e1d | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2719216 | Fluzone 2025-2026 trivalent vaccine Injectable Suspension | PSN | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2719212 | Fluzone 2025-2026 vaccine 0.5 ML Prefilled Syringe | PSN | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2709236 | influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe | PSN | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2709231 | influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) Injectable Suspension | PSN | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2719212 | 0.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Prefilled Syringe [Fluzone 2025-2026] | SBD | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2719216 | influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Injectable Suspension [Fluzone 2025-2026] | SBD | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2709236 | 0.5 ML influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Prefilled Syringe | SCD | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2709231 | influenza A virus A/Croatia/10136RV/2023 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Victoria/4897/2022 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Injectable Suspension | SCD | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2719216 | Fluzone 2025-2026 trivalent vaccine Injectable Suspension | SY | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2719212 | Fluzone 2025-2026 vaccine 0.5 ML Prefilled Syringe | SY | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2709236 | influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) 0.5 mL Prefilled Syringe | SY | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
| 2709231 | influenza virus vaccine 2025 (trivalent - Croatia/Victoria/Michigan) Injectable Suspension | SY | 5fe0ce14-bc11-4b43-b002-7efdca0d3003 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49281-643-15 | 49281064315 | 1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-643-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-643-78) | 2025-07-01 | 2026-06-30 | No | No | Historical | |
| 49281-643-78 | 49281064378 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |