FLUZONE HIGH DOSE NORTHERN HEMISPHERE
- Product NDC
- 63552-722
- 11-digit product format
- 635520722
- Labeler code
- 63552
- Product ID
- 63552-722_42c83754-08e7-5327-e063-6294a90a126e
- 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
- Patheon Manufacturing Services LLC
- Application
- BLA103914
- Marketing category
- BLA
- Marketing start
- 2025-09-01
- 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
- 60; 60; 60 ug/.5mL; ug/.5mL; ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FLUZONE HIGH DOSE NORTHERN HEMISPHERE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) | 60 ug/.5mL |
| INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) | 60 ug/.5mL |
| INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED) | 60 ug/.5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63552-722-05 | FLUZONE HIGH DOSE NORTHERN HEMISPHERE | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, SUSPENSION | 0.5 | | 1 |
| 63552-722-10 | FLUZONE HIGH DOSE NORTHERN HEMISPHERE | 5 in 1 PACKAGE | INJECTION, SUSPENSION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63552-722-05 | 63552072205 | 0.5 mL in 1 SYRINGE, GLASS | 0.5 ml | | | | Historical |
| 63552-722-10 | 63552072210 | 5 SYRINGE, GLASS in 1 PACKAGE (63552-722-10) / .5 mL in 1 SYRINGE, GLASS (63552-722-05) | | 2025-09-01 | No | No | Current |