PEDIARIX

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerGlaxoSmithKline Biologicals SA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5816081152
10 SYRINGE in 1 CARTON (58160-811-52) / .5 mL in 1 SYRINGE (58160-811-43)

Annotations

UNII (FDA Substance ID)

8C367IY4EY

BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8C367IY4EY",
    "rxcui": null,
    "inchikey": null,
    "display_name": "BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "spl_meta": {
    "b63c4c7d-3dbf-419d-84cc-2c1957b92be7": {
      "match": "brand_token",
      "title": "PEDIARIX (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE COMBINED) INJECTION, SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "30",
      "published_date": "2026-05-25"
    }
  },
  "productid": "58160-811_97c7ea5c-c93e-4bba-9f03-b0e88ed68439",
  "productndc": "58160-811",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "VACCINE",
  "substance_name": "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)",
  "proprietary_name": "PEDIARIX",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL; [iU]/.5mL",
  "application_number": "BLA103907",
  "marketing_category": "BLA",
  "nonproprietary_name": "Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined",
  "start_marketing_date": "20090724",
  "active_numerator_strength": "25; 8; 25; 10; 25; 10; 40; 8; 32"
}

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