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United States · US · US:63323-883_89998b96-8ca7-4eb1-98a4-e533420d0e72
Doxorubicin Hydrochloride
Orange BookUNIISPLATC L01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeL01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1163323883051 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05) / 5 mL in 1 VIAL, SINGLE-DOSE
- ndc1163323883101 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-10) / 10 mL in 1 VIAL, SINGLE-DOSE
- ndc1163323883301 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-30) / 25 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
A063277
AP
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": "63323-883_89998b96-8ca7-4eb1-98a4-e533420d0e72",
"productndc": "63323-883",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "063277",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Oct 26, 1995"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DOXORUBICIN HYDROCHLORIDE",
"proprietary_name": "Doxorubicin Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA063277",
"marketing_category": "ANDA",
"nonproprietary_name": "DOXORUBICIN HYDROCHLORIDE",
"start_marketing_date": "20000414",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01DB01.
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