INFASURF

UNIISPL

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

Identification

ManufacturerONY Biotech Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6193845603
1 VIAL, GLASS in 1 CARTON (61938-456-03) / 3 mL in 1 VIAL, GLASS
ndc11
6193845606
1 VIAL, GLASS in 1 CARTON (61938-456-06) / 6 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

Q4K217VGA9

CALFACTANT

RxCUI 232539

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Q4K217VGA9",
    "rxcui": "232539",
    "inchikey": null,
    "display_name": "CALFACTANT",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ENDOTRACHEAL",
  "spl_meta": {
    "315c128a-272d-4c57-bfbe-1a8b3402af08": {
      "match": "brand_token",
      "title": "INFASURF (CALFACTANT) SUSPENSION [ONY BIOTECH INC.]",
      "spl_version": "14",
      "published_date": "2026-04-02"
    }
  },
  "productid": "61938-456_49ede145-f336-f2b5-e063-6294a90aefce",
  "productndc": "61938-456",
  "dosage_form": "SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALFACTANT",
  "proprietary_name": "INFASURF",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA020521",
  "marketing_category": "BLA",
  "nonproprietary_name": "calfactant",
  "start_marketing_date": "19991018",
  "active_numerator_strength": "35.7"
}

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