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United States · US · US:25021-263_97cdef7c-93c7-4c7a-9a51-fc260a6a4521
Doxorubicin Hydrochloride Liposome
Orange BookUNIISPLATC L01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeL01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1125021263101 VIAL in 1 CARTON (25021-263-10) / 10 mL in 1 VIAL
- ndc1125021263251 VIAL in 1 CARTON (25021-263-25) / 25 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
A219881
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": "25021-263_97cdef7c-93c7-4c7a-9a51-fc260a6a4521",
"productndc": "25021-263",
"dosage_form": "INJECTION, SUSPENSION, LIPOSOMAL",
"orange_book": {
"appl_no": "219881",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG/10ML (2MG/ML)",
"product_no": "001",
"approval_date": "Feb 3, 2026"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG/25ML (2MG/ML)",
"product_no": "002",
"approval_date": "Feb 3, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXORUBICIN HYDROCHLORIDE",
"proprietary_name": "Doxorubicin Hydrochloride Liposome",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA219881",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxorubicin Hydrochloride",
"start_marketing_date": "20260301",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01DB01.
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