PEDIARIX - 58160-811-52 - (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined)

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Drug Information of PEDIARIX

Product NDC: 58160-811
Proprietary Name: PEDIARIX
Non Proprietary Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Active Ingredient(s): 25; 8; 25; 10; 25; 10; 40; 8; 32    ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL & nbsp;   Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Administration Route(s): INTRAMUSCULAR
Dosage Form(s): INJECTION, SUSPENSION
Coding System: National Drug Codes(NDC)

Labeler Information of PEDIARIX

Product NDC: 58160-811
Labeler Name: GlaxoSmithKline Biologicals SA
Product Type: VACCINE
FDA Application Number: BLA103907
Marketing Category: BLA
Start Marketing Date: 20090724

Package Information of PEDIARIX

Package NDC: 58160-811-52
Package Description: 10 SYRINGE in 1 CARTON (58160-811-52) > .5 mL in 1 SYRINGE (58160-811-43)

NDC Information of PEDIARIX

NDC Code 58160-811-52
Proprietary Name PEDIARIX
Package Description 10 SYRINGE in 1 CARTON (58160-811-52) > .5 mL in 1 SYRINGE (58160-811-43)
Product NDC 58160-811
Product Type Name VACCINE
Non Proprietary Name Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Dosage Form Name INJECTION, 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); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANT
Strength Number 25; 8; 25; 10; 25; 10; 40; 8; 32
Strength Unit ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.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],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient]

Complete Information of PEDIARIX


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