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United States · US · US:0338-0080_dc55e584-6c92-4cd3-ad37-25029cf15368
Doxorubicin Hydrochloride Liposome
Orange BookUNIISPLATC L01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Company
CountryUS (United States)
ATC codeL01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103380080011 VIAL, SINGLE-USE in 1 CARTON (0338-0080-01) / 10 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
N050718
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "82F2G7BL4E",
"rxcui": "142433",
"inchikey": "MWWSFMDVAYGXBV-RUELKSSGSA-N",
"display_name": "DOXORUBICIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"f6508535-e7a7-4e50-8d0c-43deda8d0d08": {
"match": "brand_token",
"title": "DOXORUBICIN HYDROCHLORIDE INJECTABLE, LIPOSOMAL [BLUEPOINT LABORATORIES]",
"spl_version": "5",
"published_date": "2026-05-25"
}
},
"productid": "0338-0080_dc55e584-6c92-4cd3-ad37-25029cf15368",
"productndc": "0338-0080",
"dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL",
"orange_book": {
"appl_no": "050718",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "20MG/10ML (2MG/ML)",
"product_no": "001",
"approval_date": "Nov 17, 1995"
},
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "50MG/25ML (2MG/ML)",
"product_no": "002",
"approval_date": "Jun 13, 2000"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXORUBICIN HYDROCHLORIDE",
"proprietary_name": "Doxorubicin Hydrochloride Liposome",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050718",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Doxorubicin Hydrochloride Liposome",
"start_marketing_date": "20190815",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01DB01.
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