FLUZONE QUADRIVALENT
- Product NDC
- 49281-520
- 11-digit product format
- 492810520
- Labeler code
- 49281
- Product ID
- 49281-520_f5da9c8e-5601-41eb-acdc-65ddc41a6599
- Type
- VACCINE
- Nonproprietary name
- INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Sanofi Pasteur Inc.
- Application
- BLA103914
- Marketing category
- BLA
- Marketing start
- 2020-07-02
- Marketing end
- 2021-06-30
- Substance
- INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/WASHINGTON/02/2019 ANTIGEN (FORMALDEHYDE INACTIVATED)
- Active strength
- 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| 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 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49281-520-25 | 49281052025 | 10 SYRINGE, GLASS in 1 PACKAGE (49281-520-25) > .25 mL in 1 SYRINGE, GLASS (49281-520-00) | 2020-07-02 | 2021-06-30 | No | No | Current |