58160-811 : Pediarix Intramuscular Injection, Suspension

Labeler: Glaxosmithkline Biologicals Sa
Product Type: Vaccine
Drug Name:  Pediarix
Dosage Form: Intramuscular Injection, Suspension
Application #: BLA103907
Rev. Date: 

NDC Package Codes:

  • 58160-811-52: 10 SYRINGE IN 1 CARTON (58160‑811‑52) > .5 ML IN 1 SYRINGE (58160‑811‑43)

Active Ingredients:

  • 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)

Dosage Strength:

  • 25 ug/.5mL
  • 8 ug/.5mL
  • 25 ug/.5mL
  • 10 [iU]/.5mL
  • 25 [iU]/.5mL
  • 10 ug/.5mL
  • 40 [iU]/.5mL
  • 8 [iU]/.5mL
  • 32 [iU]/.5mL

Pharmaceutical Classes:

  • Inactivated Corynebacterium Diphtheriae Vaccine [EPC]
  • Actively Acquired Immunity [PE]
  • Vaccines
  • Inactivated [Chemical/Ingredient]
  • Diphtheria Toxoid [Chemical/Ingredient]
  • Inactivated Clostridium Tetani Vaccine [EPC]
  • Tetanus Toxoid [Chemical/Ingredient]
  • Inactivated Bordetella Pertussis Vaccine [EPC]
  • Pertussis Vaccine [Chemical/Ingredient]
  • Inactivated Poliovirus Vaccine [EPC]
  • Poliovirus Vaccine [Chemical/Ingredient]


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NDC 58160-811 QR Code

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