United States · FDA National Drug Code directory

PEDIARIX

A source-listed medicine record.

Factual source checks only. This page is not a clinically reviewed monograph. Historical or discontinued records may be included; listing does not confirm approval, current availability or pharmacy stock.

Medicine identity

Source reference
58160-811_97c7ea5c-c93e-4bba-9f03-b0e88ed68439
Product NDC
58160-811
Form
INJECTION, SUSPENSION
Composition / generic term
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Labeler
GlaxoSmithKline Biologicals SA
Marketing category
BLA
Marketing start / end (source format)
20090724
Source listing expiry
20271231

Source-listed ingredients

  • CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) — 25 [iU]/.5mL
  • CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) — 10 [iU]/.5mL
  • BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) — 25 ug/.5mL
  • BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) — 25 ug/.5mL
  • BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) — 8 ug/.5mL
  • HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN — 10 ug/.5mL
  • POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) — 40 [iU]/.5mL
  • POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) — 8 [iU]/.5mL
  • POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) — 32 [iU]/.5mL

These values do not establish equivalence or a dose recommendation.

Packages

  • 10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43) · 58160-811-52

Source and coverage

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Snapshot retrieved: 2026-09-17. This is the acquisition date, not a medical review date.

Clinical information, images and comparisons appear only when separately reviewed for this record. Coverage may be incomplete. Ask a pharmacist or clinician about your treatment.

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