🇺🇸
United States · US · US:0009-5093_ec48409f-8260-42aa-89bc-222c2db99ea3
Ellence
Orange BookUNIISPLATC L01DB03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeL01DB03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100095093101 VIAL, SINGLE-DOSE in 1 CARTON (0009-5093-10) / 100 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
22966TX7J5
EPIRUBICIN HYDROCHLORIDE
RxCUI 203213
Orange Book
N050778
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "22966TX7J5",
"rxcui": "203213",
"inchikey": "MWWSFMDVAYGXBV-FGBSZODSSA-N",
"display_name": "EPIRUBICIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"0a03c798-a652-4895-b29c-3b521a89ba42": {
"match": "brand_token",
"title": "ELLENCE (EPIRUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
"spl_version": "25",
"published_date": "2026-05-21"
}
},
"productid": "0009-5093_ec48409f-8260-42aa-89bc-222c2db99ea3",
"productndc": "0009-5093",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "050778",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "200MG/100ML (2MG/ML)",
"product_no": "001",
"approval_date": "Sep 15, 1999"
},
{
"rs": false,
"rld": true,
"te_code": "AP",
"strength": "50MG/25ML (2MG/ML)",
"product_no": "002",
"approval_date": "Sep 15, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EPIRUBICIN HYDROCHLORIDE",
"proprietary_name": "Ellence",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050778",
"marketing_category": "NDA",
"nonproprietary_name": "epirubicin hydrochloride",
"start_marketing_date": "19990915",
"active_numerator_strength": "2"
}Related drugs
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