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United States · US · US:0338-9667_4a616d65-765b-401c-abf3-8135df106493
DOXIL
Orange BookUNIISPLATC L01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBaxter Healthcare Corporation
CountryUS (United States)
ATC codeL01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1103389667011 VIAL, SINGLE-DOSE in 1 CARTON (0338-9667-01) / 10 mL in 1 VIAL, SINGLE-DOSE
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": {
"917eddf9-1d3f-4abe-8c81-d33b066e5bae": {
"match": "brand_token",
"title": "DOXIL (DOXORUBICIN HYDROCHLORIDE) INJECTION, SUSPENSION, LIPOSOMAL [BAXTER HEALTHCARE CORPORATION]",
"spl_version": "5",
"published_date": "2026-03-18"
}
},
"productid": "0338-9667_4a616d65-765b-401c-abf3-8135df106493",
"productndc": "0338-9667",
"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": "DOXIL",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050718",
"marketing_category": "NDA",
"nonproprietary_name": "doxorubicin hydrochloride",
"start_marketing_date": "20240826",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01DB01.
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