Afluria
- Product NDC
- 33332-125
- 11-digit product format
- 333320125
- Labeler code
- 33332
- Product ID
- 33332-125_e60b3b79-2ae2-43b1-9192-9a5ed7c70d5e
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Victoria/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/Croatia/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/Austria/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Seqirus PTY LTD.
- Application
- BLA125254
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- Marketing end
- 2026-07-31
- Substance
- INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (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
- Afluria
Active Ingredients#
| Ingredient | Strength |
|---|---|
| INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
| INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33332-125-10 | Afluria | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | 16 | |
| 33332-125-11 | Afluria | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SUSPENSION | 5 | 16 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2718406 | afluria 2025-2026 vaccine 0.5 ML Injectable Suspension | PSN | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718400 | afluria 2025-2026 vaccine 0.5 ML Prefilled Syringe | PSN | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718386 | influenza virus vaccine 2025-2026 (trivalent - Croatia/Victoria/Austria) 0.5 ML Prefilled Syringe | PSN | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718403 | influenza virus vaccine 2025-2026 (trivalent - Croatia/Victoria/Austria) Injectable Suspension | PSN | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718400 | 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/Austria/1359417/2021 antigen 0.03 MG/ML Prefilled Syringe [Afluria 2025-2026] | SBD | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718406 | 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/Austria/1359417/2021 antigen 0.03 MG/ML Injectable Suspension [Afluria 2025-2026] | SBD | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718386 | 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/Austria/1359417/2021 antigen 0.03 MG/ML Prefilled Syringe | SCD | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718403 | 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/Austria/1359417/2021 antigen 0.03 MG/ML Injectable Suspension | SCD | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718406 | Afluria 2025-2026 vaccine 0.5 ML Injectable Suspension | SY | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718400 | Afluria 2025-2026 vaccine 0.5 ML Prefilled Syringe | SY | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718386 | influenza virus vaccine 2025-2026 (trivalent - Croatia/Victoria/Austria) 0.5 ML Prefilled Syringe | SY | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
| 2718403 | influenza virus vaccine 2025-2026 (trivalent - Croatia/Victoria/Austria) Injectable Suspension | SY | a06c4ead-c988-4b10-b832-4d7460fa358f | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 33332-125-10 | 33332012510 | 1 VIAL, MULTI-DOSE in 1 CARTON (33332-125-10) / 5 mL in 1 VIAL, MULTI-DOSE (33332-125-11) | 2025-07-01 | 2026-07-31 | No | No | Historical | |
| 33332-125-11 | 33332012511 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |