| Product NDC: | 49281-215 | 
| Proprietary Name: | TENIVAC | 
| Non Proprietary Name: | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 
| Active Ingredient(s): | 5; 2 [Lf]/.5mL; [Lf]/.5mL & nbsp; CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 
| Administration Route(s): | INTRAMUSCULAR | 
| Dosage Form(s): | INJECTION, SUSPENSION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 49281-215 | 
| Labeler Name: | Sanofi Pasteur Inc. | 
| Product Type: | VACCINE | 
| FDA Application Number: | BLA103171 | 
| Marketing Category: | BLA | 
| Start Marketing Date: | 20101208 | 
| Package NDC: | 49281-215-15 | 
| Package Description: | 10 SYRINGE in 1 PACKAGE (49281-215-15) > .5 mL in 1 SYRINGE | 
| NDC Code | 49281-215-15 | 
| Proprietary Name | TENIVAC | 
| Package Description | 10 SYRINGE in 1 PACKAGE (49281-215-15) > .5 mL in 1 SYRINGE | 
| Product NDC | 49281-215 | 
| Product Type Name | VACCINE | 
| Non Proprietary Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 
| Dosage Form Name | INJECTION, SUSPENSION | 
| Route Name | INTRAMUSCULAR | 
| Start Marketing Date | 20101208 | 
| Marketing Category Name | BLA | 
| Labeler Name | Sanofi Pasteur Inc. | 
| Substance Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) | 
| Strength Number | 5; 2 | 
| Strength Unit | [Lf]/.5mL; [Lf]/.5mL | 
| Pharmaceutical Classes | Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient] |