FLUZONE TIV SH 2026
- Product NDC
- 49281-626
- 11-digit product format
- 492810626
- Labeler code
- 49281
- Product ID
- 49281-626_5b401352-1683-4309-9708-b20472557a44
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (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
- 2026-02-20
- Marketing end
- 2026-12-31
- Substance
- INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (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 TIV SH 2026
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (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 |
|---|---|---|---|---|---|---|
| 49281-626-50 | FLUZONE TIV SH 2026 | 10 in 1 PACKAGE | INJECTION, SUSPENSION | 10 | 8 | |
| 49281-626-88 | FLUZONE TIV SH 2026 | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SUSPENSION | 0.5 | 8 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2738150 | Fluzone 2026 Southern Hemisphere vaccine 0.5 mL Prefilled Syringe | PSN | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738142 | Fluzone 2026 Southern Hemisphere vaccine Injectable Suspension | PSN | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738146 | influenza virus vaccine 2026 (trivalent - Singapore/Switzerland/Michigan) 0.5 mL Prefilled Syringe | PSN | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738136 | influenza virus vaccine 2026 (trivalent - Singapore/Switzerland/Michigan) Injectable Suspension | PSN | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738150 | 0.5 ML influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Prefilled Syringe [Fluzone 2026 Southern Hemisphere] | SBD | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738142 | influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Injectable Suspension [Fluzone 2026 Southern Hemisphere] | SBD | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738146 | 0.5 ML influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Prefilled Syringe | SCD | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738136 | influenza A virus A/Singapore/GP20238/2024 (H3N2) antigen 0.03 MG/ML / influenza A virus A/Switzerland/6849/2025 (H1N1) antigen 0.03 MG/ML / influenza B virus B/Michigan/01/2021 antigen 0.03 MG/ML Injectable Suspension | SCD | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738150 | Fluzone 2026 Southern Hemisphere vaccine 0.5 mL Prefilled Syringe | SY | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738142 | Fluzone 2026 Southern Hemisphere vaccine Injectable Suspension | SY | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738146 | influenza virus vaccine 2026 (trivalent - Singapore/Switzerland/Michigan) 0.5 mL Prefilled Syringe | SY | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
| 2738136 | influenza virus vaccine 2026 (trivalent - Singapore/Switzerland/Michigan) Injectable Suspension | SY | ced9a8b6-ef2c-a620-c61c-ff9374249543 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49281-626-50 | 49281062650 | 10 SYRINGE, GLASS in 1 PACKAGE (49281-626-50) / .5 mL in 1 SYRINGE, GLASS (49281-626-88) | 2026-02-20 | 2026-12-31 | No | No | Historical | |
| 49281-626-88 | 49281062688 | 0.5 mL in 1 SYRINGE, GLASS | 0.5 ml | Historical |