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"52125-848-08" National Drug Code (NDC)

Adacel Tdap .5 mL in 1 VIAL (52125-848-08)
(REMEDYREPACK INC.)

NDC Code52125-848-08
Package Description.5 mL in 1 VIAL (52125-848-08)
Product NDC52125-848
Product Type NameVACCINE
Proprietary NameAdacel Tdap
Proprietary Name SuffixTdap
Non-Proprietary NameClostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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 FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20151114
Marketing Category NameBLA
Application NumberBLA125111
ManufacturerREMEDYREPACK INC.
Substance NameBORDETELLA 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)
Strength5; 5; 3; 2.5; 5; 2
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL
Pharmacy ClassesInactivated 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 Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [Chemical/Ingredient],Vaccines, Inactivated [Chemical/Ingredient],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]

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