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United States · US · US:71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69
daunorubicin hydrochloride
Orange BookUNIISPLATC L01DB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01DB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11712881820510 VIAL, SINGLE-DOSE in 1 CARTON (71288-182-05) / 4 mL in 1 VIAL, SINGLE-DOSE (71288-182-04)
Annotations
UNII (FDA Substance ID)
UD984I04LZ
DAUNORUBICIN HYDROCHLORIDE
RxCUI 81992
Orange Book
A065035
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": "71288-182_7ad07c28-3a0a-4321-a2d8-fb1e9b6a9e69",
"productndc": "71288-182",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "065035",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 5MG BASE/ML",
"product_no": "001",
"approval_date": "Jan 24, 2000"
}
],
"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": "ANDA065035",
"marketing_category": "ANDA",
"nonproprietary_name": "daunorubicin hydrochloride",
"start_marketing_date": "20250601",
"active_numerator_strength": "5"
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