FLUZONE High-Dose Quadrivalent Northern Hemisphere
- Product NDC
- 49281-122
- 11-digit product format
- 492810122
- Labeler code
- 49281
- Product ID
- 49281-122_a7395061-e320-4ee2-aa43-b765792d4c41
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/Victoria/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Sanofi Pasteur Inc.
- Application
- BLA103914
- Marketing category
- BLA
- Marketing start
- 2022-07-01
- Marketing end
- 2023-07-01
- Substance
- INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 60 ug/.7mL; ug/.7mL; ug/.7mL; ug/.7mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49281-122-65 | 49281012265 | 10 SYRINGE, GLASS in 1 PACKAGE (49281-122-65) > .7 mL in 1 SYRINGE, GLASS (49281-122-88) | 2022-07-01 | 2023-07-01 | No | No | Current |