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United States · US · US:68727-712_846f5d71-faab-42a5-85d6-d83626b7bf3c

ZEPZELCA

Orange BookUNIISPLATC L01XX69

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

Identification

ManufacturerJazz Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01XX69
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6872771201
    8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01)

Annotations

UNII (FDA Substance ID)
2CN60TN6ZS
LURBINECTEDIN
RxCUI 2374729
Orange Book
N213702
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2CN60TN6ZS",
    "rxcui": "2374729",
    "inchikey": "YDDMIZRDDREKEP-HWTBNCOESA-N",
    "display_name": "LURBINECTEDIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "632bb50c-3bcb-4c85-9056-fc33410550ae": {
      "match": "brand_token",
      "title": "ZEPZELCA (LURBINECTEDIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2026-03-16"
    }
  },
  "productid": "68727-712_846f5d71-faab-42a5-85d6-d83626b7bf3c",
  "productndc": "68727-712",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "213702",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 15, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LURBINECTEDIN",
  "proprietary_name": "ZEPZELCA",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA213702",
  "marketing_category": "NDA",
  "nonproprietary_name": "Lurbinectedin",
  "start_marketing_date": "20200615",
  "active_numerator_strength": ".5"
}

Related drugs

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