NDC 58160-811

PEDIARIX

Diphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined

PEDIARIX is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Glaxosmithkline Biologicals Sa. The primary component is Bordetella Pertussis Filamentous Hemagglutinin Antigen (formaldehyde Inactivated); Bordetella Pertussis Pertactin Antigen (formaldehyde Inactivated); Bordetella Pertussis Toxoid Antigen (formaldehyde, Glutaraldehyde Inactivated); Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated); Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated); Hepatitis B Virus Subtype Adw2 Hbsag Surface Protein Antigen; Poliovirus Type 1 Antigen (formaldehyde Inactivated); Poliovirus Type 2 Antigen (formaldehyde Inactivated); Poliovirus Type 3 Antigen (formaldehyde Inactivated).

Product ID58160-811_11ed1826-1e2e-40b3-a2cc-c53bf2c4e177
NDC58160-811
Product TypeVaccine
Proprietary NamePEDIARIX
Generic NameDiphtheria And Tetanus Toxoids And Acellular Pertussis Adsorbed, Hepatitis B (recombinant) And Inactivated Poliovirus Vaccine Combined
Dosage FormInjection, Suspension
Route of AdministrationINTRAMUSCULAR
Marketing Start Date2009-07-24
Marketing CategoryBLA / BLA
Application NumberBLA103907
Labeler NameGlaxoSmithKline Biologicals SA
Substance NameBORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)
Active Ingredient Strength25 ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL
Pharm ClassesActively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 58160-811-52

10 SYRINGE in 1 CARTON (58160-811-52) > .5 mL in 1 SYRINGE (58160-811-43)
Marketing Start Date2009-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58160-811-52 [58160081152]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-08-25

NDC 58160-811-46 [58160081146]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2012-08-22

NDC 58160-811-43 [58160081143]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Billing UnitML
Marketing Start Date2010-08-25

NDC 58160-811-51 [58160081151]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Marketing Start Date2010-04-06
Marketing End Date2013-10-30

NDC 58160-811-01 [58160081101]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2012-04-13

NDC 58160-811-11 [58160081111]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2012-04-13

NDC 58160-811-41 [58160081141]

PEDIARIX INJECTION, SUSPENSION
Marketing CategoryBLA
Application NumberBLA103907
Product TypeVACCINE
Marketing Start Date2009-07-24
Marketing End Date2013-10-30

Drug Details

Active Ingredients

IngredientStrength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)25 [iU]/.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]
  • 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]
  • Pertussis Vaccine [CS]
  • Inactivated Bordetella Pertussis Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Vaccines
  • Inactivated [CS]

Trademark Results [PEDIARIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDIARIX
PEDIARIX
78125641 2978215 Live/Registered
GLAXOSMITHKLINE BIOLOGICALS S.A.
2002-05-02
PEDIARIX
PEDIARIX
78125636 3090864 Live/Registered
GLAXOSMITHKLINE LLC
2002-05-02
PEDIARIX
PEDIARIX
78125385 not registered Dead/Abandoned
SmithKline Beecham Corporation
2002-05-01
PEDIARIX
PEDIARIX
78080467 2730703 Live/Registered
Glaxosmithkline Biologicals S.A.
2001-08-22
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