YONDELIS

Orange BookUNIISPLATC L01CX01

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

Identification

ManufacturerJanssen Products, LP

CountryUS (United States)

ATC codeL01CX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5967661001
20 mL in 1 VIAL, SINGLE-USE (59676-610-01)

Annotations

UNII (FDA Substance ID)

ID0YZQ2TCP

TRABECTEDIN

RxCUI 1716278

Orange Book

N207953

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ID0YZQ2TCP",
    "rxcui": "1716278",
    "inchikey": "PKVRCIRHQMSYJX-AIFWHQITSA-N",
    "display_name": "TRABECTEDIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "472bd78e-be17-4b9d-90f4-9482c3aec9ff": {
      "match": "brand_token",
      "title": "YONDELIS (TRABECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JANSSEN PRODUCTS, LP]",
      "spl_version": "16",
      "published_date": "2026-01-23"
    }
  },
  "productid": "59676-610_354fa826-08c3-4ce1-b1fb-16e63ad09253",
  "productndc": "59676-610",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207953",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 23, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRABECTEDIN",
  "proprietary_name": "YONDELIS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA207953",
  "marketing_category": "NDA",
  "nonproprietary_name": "Trabectedin",
  "start_marketing_date": "20151023",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code L01CX01.

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