🇺🇸
United States · US · US:0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699
Daunorubicin Hydrochloride
Orange BookUNIISPLATC L01DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL01DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014395511010 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01)
Annotations
UNII (FDA Substance ID)
UD984I04LZ
DAUNORUBICIN HYDROCHLORIDE
RxCUI 81992
Orange Book
N050731
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "UD984I04LZ",
"rxcui": "81992",
"inchikey": "GUGHGUXZJWAIAS-QQYBVWGSSA-N",
"display_name": "DAUNORUBICIN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"9705fa12-499e-41a3-8fb4-f6df0858b851": {
"match": "brand_token",
"title": "DAUNORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HISUN PHARMACEUTICALS USA, INC.]",
"spl_version": "13",
"published_date": "2026-01-20"
}
},
"productid": "0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699",
"productndc": "0143-9551",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "050731",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Jan 30, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAUNORUBICIN HYDROCHLORIDE",
"proprietary_name": "Daunorubicin Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "NDA050731",
"marketing_category": "NDA",
"nonproprietary_name": "Daunorubicin Hydrochloride",
"start_marketing_date": "20180102",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01DB02.
- NOCerubidinSanofi-aventis Norge (3)
- FICerubidinRhone-Poulenc Rorer A/S
- IECerubidin 20 mg Powder for Concentrate for Solution for InfusionSanofi-Aventis Ireland Limited T/A SANOFI
- DKCerubidineOrifarm A/S
- CACERUBIDINESEARCHLIGHT PHARMA INC
- BECerubidine 20 mgSanofi Belgium
- NLCerubidine 20mg, poeder en oplosmiddel voor oplossing voor injectieSanofi B.V.
- 🇨🇭DaunoblastinPfizer AG
Access this data programmatically
Query Daunorubicin Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.