Flucelvax
- Product NDC
- 83703-084
- 11-digit product format
- 837030084
- Labeler code
- 83703
- Product ID
- 83703-084_49ddaf45-cca6-f3c5-e063-6394a90a32f3
- 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
- Bamboo US BidCo LLC
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Flucelvax
Active Ingredients#
Ingredient, Strength table| 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 table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83703-084-03 | Flucelvax | 10 in 1 CARTON | INJECTION, SUSPENSION | 10 | | 1 |
| 83703-084-04 | Flucelvax | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SUSPENSION | 0.5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 83703-084-03 | 83703008403 | 10 SYRINGE, GLASS in 1 CARTON (83703-084-03) / .5 mL in 1 SYRINGE, GLASS (83703-084-04) | | 2025-07-01 | 2026-07-31 | No | No | Historical |
| 83703-084-04 | 83703008404 | 0.5 mL in 1 SYRINGE, GLASS | 0.5 ml | | | | | Historical |