Product NDC: | 63851-611 |
Proprietary Name: | Flucelvax |
Non Proprietary Name: | INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/WISCONSIN/1/2010) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Active Ingredient(s): | 15; 15; 15 ug/.5mL; ug/.5mL; ug/.5mL & nbsp; INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/WISCONSIN/1/2010) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | INJECTION, SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63851-611 |
Labeler Name: | Novartis Vaccines and Diagnostics GmbH |
Product Type: | VACCINE |
FDA Application Number: | BLA125408 |
Marketing Category: | BLA |
Start Marketing Date: | 20121130 |
Package NDC: | 63851-611-01 |
Package Description: | 10 SYRINGE, GLASS in 1 CARTON (63851-611-01) > .5 mL in 1 SYRINGE, GLASS (63851-611-11) |
NDC Code | 63851-611-01 |
Proprietary Name | Flucelvax |
Package Description | 10 SYRINGE, GLASS in 1 CARTON (63851-611-01) > .5 mL in 1 SYRINGE, GLASS (63851-611-11) |
Product NDC | 63851-611 |
Product Type Name | VACCINE |
Non Proprietary Name | INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA B VIRUS B/WISCONSIN/1/2010) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Dosage Form Name | INJECTION, SUSPENSION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20121130 |
Marketing Category Name | BLA |
Labeler Name | Novartis Vaccines and Diagnostics GmbH |
Substance Name | INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/WISCONSIN/1/2010) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Strength Number | 15; 15; 15 |
Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
Pharmaceutical Classes |