NDC 63361-243

VAXELIS

Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine

VAXELIS is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Mcm Vaccine Co.. The primary component is Corynebacterium 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.

Product ID63361-243_153c5767-222d-4eff-8f11-bea7071a6ba2
NDC63361-243
Product TypeVaccine
Proprietary NameVAXELIS
Generic NameDiphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2018-12-21
Marketing CategoryBLA / BLA
Application NumberBLA125563
Labeler NameMCM 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
Active Ingredient Strength15 [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
Pharm 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]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63361-243-10

10 VIAL, SINGLE-DOSE in 1 PACKAGE (63361-243-10) > .5 mL in 1 VIAL, SINGLE-DOSE (63361-243-58)
Marketing Start Date2018-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63361-243-58 [63361024358]

VAXELIS INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125563
Product TypeVACCINE
Marketing Start Date2018-12-21

NDC 63361-243-10 [63361024310]

VAXELIS INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125563
Product TypeVACCINE
Marketing Start Date2018-12-21

Drug Details

Active Ingredients

IngredientStrength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)15 [Lf]/.5mL

Pharmacological Class

  • Inactivated 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]

NDC Crossover Matching brand name "VAXELIS" or generic name "Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine"

NDCBrand NameGeneric Name
63361-243VAXELISdiphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine
63361-245VAXELISDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine

Trademark Results [VAXELIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VAXELIS
VAXELIS
88276439 not registered Live/Pending
MCM VACCINE CO.
2019-01-25
VAXELIS
VAXELIS
87177140 not registered Live/Pending
MCM VACCINE CO.
2016-09-20
VAXELIS
VAXELIS
76059220 not registered Dead/Abandoned
Connaught Technology Corporation
2000-05-30

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