NDC 49281-400

Adacel TDaP

Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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

Adacel TDaP is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Sanofi Pasteur Inc.. The primary component is Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae 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 ID49281-400_3aca07e6-db77-4e8b-9a20-5d07b8c658b7
NDC49281-400
Product TypeVaccine
Proprietary NameAdacel TDaP
Generic NameClostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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 Date2005-06-10
Marketing CategoryBLA / BLA
Application NumberBLA125111
Labeler NameSanofi Pasteur Inc.
Substance NameCLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE 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 Strength5 [Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL
Pharm ClassesInactivated Clostridium Tetani Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Tetanus Toxoid [CS],Inactivated Corynebacterium Diphtheriae Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Inactivated [CS],Diphtheria 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]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49281-400-05

5 VIAL in 1 PACKAGE (49281-400-05) > .5 mL in 1 VIAL (49281-400-58)
Marketing Start Date2005-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49281-400-58 [49281040058]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2013-08-23

NDC 49281-400-88 [49281040088]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2013-08-23

NDC 49281-400-20 [49281040020]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2017-11-17

NDC 49281-400-89 [49281040089]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2017-11-17

NDC 49281-400-15 [49281040015]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2005-06-10

NDC 49281-400-10 [49281040010]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Billing UnitML
Marketing Start Date2005-06-10

NDC 49281-400-05 [49281040005]

Adacel TDaP INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA125111
Product TypeVACCINE
Marketing Start Date2005-06-10

Drug Details

Active Ingredients

IngredientStrength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [Lf]/.5mL

Pharmacological Class

  • Inactivated Clostridium Tetani Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Vaccines
  • Inactivated [CS]
  • Tetanus Toxoid [CS]
  • Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Vaccines
  • Inactivated [CS]
  • Diphtheria 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]

NDC Crossover Matching brand name "Adacel TDaP" or generic name "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated), Corynebacterium Diphtheriae 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"

NDCBrand NameGeneric Name
49281-400AdacelCLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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
50090-1079CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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 ANTIGENCLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED), CORYNEBACTERIUM DIPHTHERIAE 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

Trademark Results [Adacel]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADACEL
ADACEL
78469483 3034913 Live/Registered
SANOFI PASTEUR INC.
2004-08-18
ADACEL
ADACEL
78261501 3053019 Live/Registered
ADACEL INC.
2003-06-12
ADACEL
ADACEL
76473861 3068614 Live/Registered
SANOFI PASTEUR INC.
2002-12-11
ADACEL
ADACEL
75704888 not registered Dead/Abandoned
Connaught Technology Corporation
1999-05-14

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