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United States · US · US:15054-0043_72b1786a-3437-4799-8214-f37b5be5607c
Onivyde
In shortageOrange BookUNIISPLATC L01CE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIpsen Biopharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01CE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1115054004311 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
042LAQ1IIS
IRINOTECAN HYDROCHLORIDE
RxCUI 153329
Orange Book
N207793
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Irinotecan Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "042LAQ1IIS",
"rxcui": "153329",
"inchikey": "KLEAIHJJLUAXIQ-JDRGBKBRSA-N",
"display_name": "IRINOTECAN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"c8b58efa-1820-48a4-b70d-62918fc4abfc": {
"match": "brand_token",
"title": "ONIVYDE (IRINOTECAN HYDROCHLORIDE) INJECTION, POWDER, FOR SOLUTION [IPSEN BIOPHARMACEUTICALS, INC.]",
"spl_version": "9",
"published_date": "2025-03-05"
}
},
"productid": "15054-0043_72b1786a-3437-4799-8214-f37b5be5607c",
"productndc": "15054-0043",
"dosage_form": "INJECTION, POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "207793",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)",
"product_no": "001",
"approval_date": "Oct 22, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IRINOTECAN HYDROCHLORIDE",
"shortage_reason": "Irinotecan Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "Onivyde",
"active_ingred_unit": "mg/mL",
"application_number": "NDA207793",
"marketing_category": "NDA",
"nonproprietary_name": "IRINOTECAN HYDROCHLORIDE",
"start_marketing_date": "20151022",
"active_numerator_strength": "4.3"
}Related drugs
Other records sharing ATC code L01CE02.
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