DAPTACEL - 49281-286-10 - (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)

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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: 49281-286-10
Package Description: 10 VIAL in 1 PACKAGE (49281-286-10) > .5 mL in 1 VIAL

NDC Information of DAPTACEL

NDC Code 49281-286-10
Proprietary Name DAPTACEL
Package Description 10 VIAL in 1 PACKAGE (49281-286-10) > .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]

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