PEDIARIX

UNIISPL

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009075410
10 SYRINGE in 1 CARTON (50090-7541-0) / .5 mL in 1 SYRINGE (50090-7541-1)

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": "50090-7541_2428a09d-35f0-4444-ba52-f67c8210326f",
  "productndc": "50090-7541",
  "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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