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"49281-286-01" National Drug Code (NDC)

Daptacel 1 VIAL in 1 PACKAGE (49281-286-01) / .5 mL in 1 VIAL (49281-286-58)
(Sanofi Pasteur Inc.)

NDC Code49281-286-01
Package Description1 VIAL in 1 PACKAGE (49281-286-01) / .5 mL in 1 VIAL (49281-286-58)
Product NDC49281-286
Product Type NameVACCINE
Proprietary NameDaptacel
Non-Proprietary NameCorynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated), Clostridium Tetani 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 Date20020514
Marketing Category NameBLA
Application NumberBLA103666
ManufacturerSanofi Pasteur 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; 10; 5; 15
Strength Unitug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [Lf]/.5mL; [Lf]/.5mL
Pharmacy ClassesActively 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], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]

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