Curosurf

UNIISPL

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

Identification

ManufacturerChiesi USA, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1012251001
1.5 mL in 1 VIAL, GLASS (10122-510-01)
ndc11
1012251003
3 mL in 1 VIAL, GLASS (10122-510-03)

Annotations

UNII (FDA Substance ID)

KE3U2023NP

PORACTANT ALFA

RxCUI 236381

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "KE3U2023NP",
    "rxcui": "236381",
    "inchikey": null,
    "display_name": "PORACTANT ALFA",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ENDOTRACHEAL",
  "spl_meta": {
    "99bef307-00bd-4379-9f45-ede1380e74d4": {
      "match": "brand_token",
      "title": "CUROSURF (PORACTANT ALFA) SUSPENSION [CHIESI USA, INC.]",
      "spl_version": "45",
      "published_date": "2025-12-15"
    }
  },
  "productid": "10122-510_6b713a41-2648-43f4-9a10-cc41a7e83ca0",
  "productndc": "10122-510",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PORACTANT ALFA",
  "proprietary_name": "Curosurf",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA020744",
  "marketing_category": "BLA",
  "nonproprietary_name": "poractant alfa",
  "start_marketing_date": "19991118",
  "active_numerator_strength": "80"
}

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