NDC 58160-842

BOOSTRIX

Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed

BOOSTRIX is a Intramuscular Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Bordetella Pertussis Toxoid Antigen (formaldehyde, Glutaraldehyde Inactivated); Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Pertactin Antigen (formaldehyde Inactivated).

Product ID58160-842_1374977a-0952-44dc-a1ce-2bdd727ed2ea
NDC58160-842
Product TypeVaccine
Proprietary NameBOOSTRIX
Generic NameTetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed
Dosage FormSuspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2009-07-24
Marketing CategoryBLA / BLA
Application NumberBLA125106
Labeler NameGlaxoSmithKline Biologicals SA
Substance NameCLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient Strength5 [iU]/.5mL; [iU]/.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 58160-842-11

10 VIAL in 1 CARTON (58160-842-11) > .5 mL in 1 VIAL (58160-842-01)
Marketing Start Date2009-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58160-842-52 [58160084252]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2011-01-20

NDC 58160-842-05 [58160084205]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2012-02-11

NDC 58160-842-32 [58160084232]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-11-13
Marketing End Date2012-02-11

NDC 58160-842-51 [58160084251]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Marketing Start Date2010-09-14
Marketing End Date2013-12-13

NDC 58160-842-11 [58160084211]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-07-24

NDC 58160-842-43 [58160084243]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2011-01-20

NDC 58160-842-46 [58160084246]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2012-03-06

NDC 58160-842-01 [58160084201]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-07-24

NDC 58160-842-41 [58160084241]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2013-12-13

NDC 58160-842-34 [58160084234]

BOOSTRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA125106
Product TypeVACCINE
Billing UnitML
Marketing Start Date2011-07-12

Drug Details

Active Ingredients

IngredientStrength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)5 [iU]/.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 "BOOSTRIX" or generic name "Tetanus Toxoid, Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine, Adsorbed"

NDCBrand NameGeneric Name
50090-1377BOOSTRIXTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
50090-1831BOOSTRIXTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
58160-842BOOSTRIXTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

Trademark Results [BOOSTRIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BOOSTRIX
BOOSTRIX
79269514 not registered Live/Pending
GlaxoSmithKline Biologicals S.A.
2019-08-27
BOOSTRIX
BOOSTRIX
78549441 not registered Dead/Abandoned
GlaxoSmithKline Biologicals S.A.
2005-01-18
BOOSTRIX
BOOSTRIX
76467131 2905576 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A.
2002-11-14
BOOSTRIX
BOOSTRIX
75901449 not registered Dead/Abandoned
SmithKline Beecham Biologicals, S.A.
2000-01-20
BOOSTRIX
BOOSTRIX
75131458 not registered Dead/Abandoned
SmithKline Beecham Biologicals S.A.
1996-07-09
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