Product NDC: | 58160-810 |
Proprietary Name: | INFANRIX |
Non Proprietary Name: | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Active Ingredient(s): | 25; 8; 25; 10; 25 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL & nbsp; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Administration Route(s): | INTRAMUSCULAR |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58160-810 |
Labeler Name: | GlaxoSmithKline Biologicals SA |
Product Type: | VACCINE |
FDA Application Number: | BLA103647 |
Marketing Category: | BLA |
Start Marketing Date: | 20090724 |
Package NDC: | 58160-810-52 |
Package Description: | 10 SYRINGE in 1 CARTON (58160-810-52) > .5 mL in 1 SYRINGE (58160-810-43) |
NDC Code | 58160-810-52 |
Proprietary Name | INFANRIX |
Package Description | 10 SYRINGE in 1 CARTON (58160-810-52) > .5 mL in 1 SYRINGE (58160-810-43) |
Product NDC | 58160-810 |
Product Type Name | VACCINE |
Non Proprietary Name | Diphtheria and Tetanus Toxoids 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 | 25; 8; 25; 10; 25 |
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] |