58160-811 : Pediarix Intramuscular Injection, Suspension


NDC58160-811
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:

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

NDC QR Code

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NDC 58160-811 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.