| Product NDC: | 49281-291 |
| Proprietary Name: | DECAVAC |
| 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): | SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 49281-291 |
| Labeler Name: | Sanofi Pasteur Inc. |
| Product Type: | VACCINE |
| FDA Application Number: | BLA103921 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20040324 |
| Package NDC: | 49281-291-83 |
| Package Description: | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-291-83) > .5 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 49281-291-83 |
| Proprietary Name | DECAVAC |
| Package Description | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-291-83) > .5 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 49281-291 |
| Product Type Name | VACCINE |
| Non Proprietary Name | CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Dosage Form Name | SUSPENSION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20040324 |
| 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] |