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"63361-245-10" National Drug Code (NDC)

Vaxelis 10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-245-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-245-58)
(MCM Vaccine Co.)

NDC Code63361-245-10
Package Description10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-245-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-245-58)
Product NDC63361-245
Product Type NameVACCINE
Proprietary NameVaxelis
Non-Proprietary NameDiphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus B Conjugate (meningococcal Protein Conjugate) And Hepatitis B (recombinant) Vaccine
Dosage FormINJECTION, SUSPENSION
UsageINTRAMUSCULAR
Start Marketing Date20181221
End Marketing Date20200410
Marketing Category NameBLA
Application NumberBLA125563
ManufacturerMCM Vaccine Co.
Substance 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; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN
Strength15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3
Strength Unit[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL
Pharmacy ClassesInactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria Toxoid [CS],Inactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Pertussis Vaccine [CS],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Inactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Poliovirus Vaccine [EPC],Actively Acquired Immunity [PE],Poliovirus Vaccines [CS],Vaccines, Inactivated [CS],Inactivated Hepatitis B Virus Vaccine [EPC],Actively Acquired Immunity [PE],Hepatitis B Vaccines [CS],Vaccines, Inactivated [CS],Actively Acquired Immunity [PE],Haemophilus Vaccines [CS],Inactivated Haemophilus Influenzae B Vaccine [EPC],Vaccines, Inactivated [CS]

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