Product NDC: | 49281-513 |
Proprietary Name: | FLUZONE QUADRIVALENT |
Non Proprietary Name: | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Active Ingredient(s): | 7.5; 7.5; 7.5; 7.5 ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL & nbsp; INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION, SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 49281-513 |
Labeler Name: | Sanofi Pasteur Inc. |
Product Type: | VACCINE |
FDA Application Number: | BLA103914 |
Marketing Category: | BLA |
Start Marketing Date: | 20130610 |
Package NDC: | 49281-513-25 |
Package Description: | 10 SYRINGE, GLASS in 1 PACKAGE (49281-513-25) > .25 mL in 1 SYRINGE, GLASS (49281-513-00) |
NDC Code | 49281-513-25 |
Proprietary Name | FLUZONE QUADRIVALENT |
Package Description | 10 SYRINGE, GLASS in 1 PACKAGE (49281-513-25) > .25 mL in 1 SYRINGE, GLASS (49281-513-00) |
Product NDC | 49281-513 |
Product Type Name | VACCINE |
Non Proprietary Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED), and INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Dosage Form Name | INJECTION, SUSPENSION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20130610 |
Marketing Category Name | BLA |
Labeler Name | Sanofi Pasteur Inc. |
Substance Name | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-179A (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (FORMALDEHYDE INACTIVATED) |
Strength Number | 7.5; 7.5; 7.5; 7.5 |
Strength Unit | ug/.25mL; ug/.25mL; ug/.25mL; ug/.25mL |
Pharmaceutical Classes |