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United States Β· US Β· US:58160-842_5045e31e-3eda-47ac-b374-0ab16dad194e

BOOSTRIX

UNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGlaxoSmithKline Biologicals SA
CountryUS (United States)
ATC codeβ€”
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 2

  • ndc11
    5816084211
    10 VIAL in 1 CARTON (58160-842-11) / .5 mL in 1 VIAL (58160-842-01)
  • ndc11
    5816084252
    10 SYRINGE in 1 CARTON (58160-842-52) / .5 mL in 1 SYRINGE (58160-842-43)

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": {
    "cd98bff9-4602-4268-d68d-029a14a5513b": {
      "match": "brand_token",
      "title": "BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR PERTUSSIS VACCINE, ADSORBED) SUSPENSION [GLAXOSMITHKLINE BIOLOGICALS SA]",
      "spl_version": "44",
      "published_date": "2026-05-25"
    }
  },
  "productid": "58160-842_5045e31e-3eda-47ac-b374-0ab16dad194e",
  "productndc": "58160-842",
  "dosage_form": "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)",
  "proprietary_name": "BOOSTRIX",
  "active_ingred_unit": "ug/.5mL; ug/.5mL; ug/.5mL; [iU]/.5mL; [iU]/.5mL",
  "application_number": "BLA125106",
  "marketing_category": "BLA",
  "nonproprietary_name": "Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed",
  "start_marketing_date": "20090724",
  "active_numerator_strength": "8; 2.5; 8; 5; 2.5"
}

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