FLUZONE TRIVALENT NORTHERN HEMISPHERE
- Product NDC
- 49281-426
- 11-digit product format
- 492810426
- Labeler code
- 49281
- Product ID
- 49281-426_775d34bb-508b-47ef-af40-d4dbf8ea132c
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Switzerland/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/Michigan/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/Tokyo/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Application
- BLA103914
- Marketing category
- BLA
- Marketing start
- 2024-07-02
- Marketing end
- 2027-06-30
- Substance
- INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 15 ug/.5mg
- 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/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mg |
| INFLUENZA A VIRUS A/MICHIGAN/105/2025 SAN-049A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mg |
| INFLUENZA B VIRUS B/TOKYO/EIS13-175/2025 ANTIGEN (FORMALDEHYDE INACTIVATED) | 15 ug/.5mg |
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 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 103914 | Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent | Influenza Virus Vaccine | 351(a) | Rx | 2026-06-01 |
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 | Marketing start | Marketing end | Sample | Status |
|---|---|---|---|---|---|---|
| 49281-426-50 | 49281042650 | 10 SYRINGE, GLASS in 1 PACKAGE (49281-426-50) / .5 mg in 1 SYRINGE, GLASS (49281-426-88) | 2024-07-02 | 2027-06-30 | 0 | Historical |