NDC 58160-810

INFANRIX

Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed

INFANRIX 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 ID58160-810_61ec630a-fc26-4878-b587-636909a91195
NDC58160-810
Product TypeVaccine
Proprietary NameINFANRIX
Generic NameDiphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed
Dosage FormSuspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2009-07-24
Marketing CategoryBLA / BLA
Application NumberBLA103647
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 Strength10 [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],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]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 58160-810-11

10 VIAL in 1 CARTON (58160-810-11) > .5 mL in 1 VIAL (58160-810-01)
Marketing Start Date2009-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58160-810-43 [58160081043]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-09-01

NDC 58160-810-41 [58160081041]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2013-01-02

NDC 58160-810-51 [58160081051]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Marketing Start Date2010-02-24
Marketing End Date2013-01-02

NDC 58160-810-11 [58160081011]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-07-24

NDC 58160-810-52 [58160081052]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-09-01

NDC 58160-810-46 [58160081046]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2012-03-21

NDC 58160-810-01 [58160081001]

INFANRIX SUSPENSION
Marketing CategoryBLA
Application NumberBLA103647
Product TypeVACCINE
Billing UnitML
Marketing Start Date2009-07-24

Drug Details

Active Ingredients

IngredientStrength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)10 [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 "INFANRIX" or generic name "Diphtheria And Tetanus Toxoids And Acellular Pertussis Vaccine Adsorbed"

NDCBrand NameGeneric Name
50090-2883INFANRIXDiphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
58160-810INFANRIXDiphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed

Trademark Results [INFANRIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFANRIX
INFANRIX
75121742 2171713 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A.
1996-06-04
INFANRIX
INFANRIX
74385270 2095412 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A.
1993-04-29

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