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United States · US · US:42658-021_f43105cb-1807-45f2-e053-2995a90a4d6b
Daunorubicin Hydrochloride
Orange BookUNIISPLATC L01DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHisun Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeL01DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1142658021911 VIAL in 1 BOX (42658-021-91) / 4 mL in 1 VIAL
- ndc11426580219210 VIAL in 1 CARTON (42658-021-92) / 4 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
UD984I04LZ
DAUNORUBICIN HYDROCHLORIDE
RxCUI 81992
Orange Book
A208759
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": "42658-021_f43105cb-1807-45f2-e053-2995a90a4d6b",
"productndc": "42658-021",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "208759",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Apr 12, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DAUNORUBICIN HYDROCHLORIDE",
"proprietary_name": "Daunorubicin Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA208759",
"marketing_category": "ANDA",
"nonproprietary_name": "daunorubicin hydrochloride",
"start_marketing_date": "20200120",
"active_numerator_strength": "5"
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