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DAPTACEL
DAPTACEL - 49281-286-01 - (corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen)
Drug Information of DAPTACEL
| Product NDC: | 49281-286 |
| Proprietary Name: | DAPTACEL |
| Non Proprietary Name: | corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen |
| Active Ingredient(s): | 5; 5; 3; 10; 5; 15 ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL & nbsp; corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, SUSPENSION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of DAPTACEL
| Product NDC: | 49281-286 |
| Labeler Name: | Sanofi Pasteur Inc. |
| Product Type: | VACCINE |
| FDA Application Number: | BLA103666 |
| Marketing Category: | BLA |
| Start Marketing Date: | 20020514 |
Package Information of DAPTACEL
| Package NDC: | 49281-286-01 |
| Package Description: | 1 VIAL in 1 PACKAGE (49281-286-01) > .5 mL in 1 VIAL |
NDC Information of DAPTACEL
| NDC Code | 49281-286-01 |
| Proprietary Name | DAPTACEL |
| Package Description | 1 VIAL in 1 PACKAGE (49281-286-01) > .5 mL in 1 VIAL |
| Product NDC | 49281-286 |
| Product Type Name | VACCINE |
| Non Proprietary Name | corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis pertactin antigen, and bordetella pertussis fimbriae 2/3 antigen |
| Dosage Form Name | INJECTION, SUSPENSION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20020514 |
| Marketing Category Name | BLA |
| Labeler Name | Sanofi Pasteur Inc. |
| Substance Name | BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
| Strength Number | 5; 5; 3; 10; 5; 15 |
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL |
| Pharmaceutical Classes | Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Diphtheria Toxoid [Chemical/Ingredient],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Tetanus Toxoid [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [Chemical/Ingredient],Pertussis Vaccine [Chemical/Ingredient] |
