DATROWAY

UNIISPLATC L01FX35

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

Identification

ManufacturerDaiichi Sankyo Inc.

CountryUS (United States)

ATC codeL01FX35

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6559780101
1 VIAL, SINGLE-DOSE in 1 CARTON (65597-801-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

GD2OWY1DTK

DATOPOTAMAB DERUXTECAN

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "GD2OWY1DTK",
    "rxcui": null,
    "inchikey": null,
    "display_name": "DATOPOTAMAB DERUXTECAN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "2950227c-6230-4ca4-a135-46e44d9424a0": {
      "match": "brand_token",
      "title": "DATROWAY (DATOPOTAMAB DERUXTECAN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DAIICHI SANKYO INC.]",
      "spl_version": "17",
      "published_date": "2026-03-26"
    }
  },
  "productid": "65597-801_c5c6cd04-1bea-4809-a830-b1fb1ba94e97",
  "productndc": "65597-801",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DATOPOTAMAB DERUXTECAN",
  "proprietary_name": "DATROWAY",
  "active_ingred_unit": "mg/5mL",
  "application_number": "BLA761394",
  "marketing_category": "BLA",
  "nonproprietary_name": "Datopotamab Deruxtecan",
  "start_marketing_date": "20250117",
  "active_numerator_strength": "100"
}

Related drugs

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