Product NDC: | 58160-842 |
Proprietary Name: | BOOSTRIX |
Non Proprietary Name: | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
Active Ingredient(s): | 8; 2.5; 8; 5; 2.5 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL & nbsp; Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58160-842 |
Labeler Name: | GlaxoSmithKline Biologicals SA |
Product Type: | VACCINE |
FDA Application Number: | BLA125106 |
Marketing Category: | BLA |
Start Marketing Date: | 20090724 |
Package NDC: | 58160-842-11 |
Package Description: | 10 VIAL in 1 CARTON (58160-842-11) > .5 mL in 1 VIAL (58160-842-01) |
NDC Code | 58160-842-11 |
Proprietary Name | BOOSTRIX |
Package Description | 10 VIAL in 1 CARTON (58160-842-11) > .5 mL in 1 VIAL (58160-842-01) |
Product NDC | 58160-842 |
Product Type Name | VACCINE |
Non Proprietary Name | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
Dosage Form Name | SUSPENSION |
Route Name | INTRAMUSCULAR |
Start Marketing Date | 20090724 |
Marketing Category Name | BLA |
Labeler Name | GlaxoSmithKline Biologicals SA |
Substance Name | BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
Strength Number | 8; 2.5; 8; 5; 2.5 |
Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.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],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] |