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"58160-811-52" National Drug Code (NDC)

Pediarix 10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43)
(GlaxoSmithKline Biologicals SA)

NDC Code58160-811-52
Package Description10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43)
Product NDC58160-811
Product Type NameVACCINE
Proprietary NamePediarix
Non-Proprietary NameDiphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined
Dosage FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20090724
Marketing Category NameBLA
Application NumberBLA103907
ManufacturerGlaxoSmithKline Biologicals SA
Substance NameBORDETELLA 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 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)
Strength25; 8; 25; 10; 25; 10; 40; 8; 32
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL
Pharmacy ClassesActively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]

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