NDC 49281-562

QUADRACEL

Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine

QUADRACEL is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. 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).

Product ID49281-562_1d883d7e-c7bd-4d1e-a8ae-7d92916f6fe5
NDC49281-562
Product TypeVaccine
Proprietary NameQUADRACEL
Generic NameDiphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2015-03-24
Marketing CategoryBLA / BLA
Application NumberBLA125525
Labeler NameSanofi Pasteur Inc.
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)
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
Pharm ClassesInactivated 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 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]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 49281-562-10

10 VIAL, SINGLE-USE in 1 PACKAGE (49281-562-10) > .5 mL in 1 VIAL, SINGLE-USE (49281-562-58)
Marketing Start Date2015-03-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49281-562-10 [49281056210]

QUADRACEL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125525
Product TypeVACCINE
Billing UnitML
Marketing Start Date2015-03-24

NDC 49281-562-58 [49281056258]

QUADRACEL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125525
Product TypeVACCINE
Billing UnitML
Marketing Start Date2015-03-24

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]

NDC Crossover Matching brand name "QUADRACEL" or generic name "Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed And Inactivated Poliovirus Vaccine"

NDCBrand NameGeneric Name
49281-562QUADRACELdiphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine
49281-564QUADRACELdiphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine
58160-812KINRIXDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

Trademark Results [QUADRACEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUADRACEL
QUADRACEL
90407426 not registered Live/Pending
Precision Architectural Lighting, Inc.
2020-12-23
QUADRACEL
QUADRACEL
86327927 5237414 Live/Registered
SANOFI PASTEUR INC.
2014-07-03
QUADRACEL
QUADRACEL
85225589 not registered Dead/Abandoned
Sanofi Pasteur Limited/ Sanofi Pasteur Limitee
2011-01-25
QUADRACEL
QUADRACEL
77228051 not registered Dead/Abandoned
Sanofi Pasteur Limited/Sanofi Pasteur Limitee
2007-07-12
QUADRACEL
QUADRACEL
75583409 not registered Dead/Abandoned
Connaught Technology Corporation
1998-11-05
QUADRACEL
QUADRACEL
74365740 not registered Dead/Abandoned
AMERICAN CYANAMID COMPANY
1993-03-08

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