| 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 |