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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
- ndc1168727712018 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
Other records sharing ATC code L01XX69.
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