NDC 49281-286

DAPTACEL

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, And Bordetella Pertussis Fimbriae 2/3 Antigen

DAPTACEL 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.

Product ID49281-286_037e3cb5-7716-4c45-a789-7b83fd930af9
NDC49281-286
Product TypeVaccine
Proprietary NameDAPTACEL
Generic 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
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2002-05-14
Marketing CategoryBLA / BLA
Application NumberBLA103666
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
Active Ingredient Strength15 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharm ClassesInactivated Bordetella Pertussis Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Pertussis Vaccine [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 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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49281-286-01

1 VIAL in 1 PACKAGE (49281-286-01) > .5 mL in 1 VIAL (49281-286-58)
Marketing Start Date2002-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49281-286-10 [49281028610]

DAPTACEL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103666
Product TypeVACCINE
Billing UnitML
Marketing Start Date2002-05-14

NDC 49281-286-05 [49281028605]

DAPTACEL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103666
Product TypeVACCINE
Marketing Start Date2002-05-14

NDC 49281-286-01 [49281028601]

DAPTACEL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103666
Product TypeVACCINE
Marketing Start Date2002-05-14

NDC 49281-286-58 [49281028658]

DAPTACEL INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103666
Product TypeVACCINE
Billing UnitML
Marketing Start Date2013-11-11

Drug Details

Active Ingredients

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

Pharmacological Class

  • Inactivated Bordetella Pertussis Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Vaccines
  • Inactivated [CS]
  • Pertussis Vaccine [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 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]
  • Vaccines
  • Inactivated [CS]
  • Pertussis Vaccine [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 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]

Trademark Results [DAPTACEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DAPTACEL
DAPTACEL
76281766 2647103 Live/Registered
SANOFI PASTEUR INC.
2001-07-06

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