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United States · US · US:68083-249_b7814991-37d8-4928-ad83-d8fc04409c08
Doxorubicin Hydrochloride
Orange BookUNIISPLATC L01DB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeL01DB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168083249011 VIAL, SINGLE-DOSE in 1 CARTON (68083-249-01) / 25 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
82F2G7BL4E
DOXORUBICIN HYDROCHLORIDE
RxCUI 142433
Orange Book
A209825
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": "68083-249_b7814991-37d8-4928-ad83-d8fc04409c08",
"productndc": "68083-249",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "209825",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "2MG/ML",
"product_no": "001",
"approval_date": "Aug 11, 2017"
}
],
"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": "ANDA209825",
"marketing_category": "ANDA",
"nonproprietary_name": "Doxorubicin Hydrochloride",
"start_marketing_date": "20170822",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01DB01.
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