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United States · US · US:72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85
Beleodaq
Orange BookUNIISPLATC L01XH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcrotech Biopharma Inc
CountryUS (United States)
ATC codeL01XH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172893002011 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
F4H96P17NZ
BELINOSTAT
RxCUI 1543543
Orange Book
N206256
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F4H96P17NZ",
"rxcui": "1543543",
"inchikey": "NCNRHFGMJRPRSK-MDZDMXLPSA-N",
"display_name": "BELINOSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"2e8ef36b-71fa-4492-a16f-577d5f7d111d": {
"match": "brand_token",
"title": "BELEODAQ (BELINOSTAT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC]",
"spl_version": "10",
"published_date": "2025-04-09"
}
},
"productid": "72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85",
"productndc": "72893-002",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "206256",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "500MG/VIAL",
"product_no": "001",
"approval_date": "Jul 3, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BELINOSTAT",
"proprietary_name": "Beleodaq",
"active_ingred_unit": "mg/10mL",
"application_number": "NDA206256",
"marketing_category": "NDA",
"nonproprietary_name": "Belinostat",
"start_marketing_date": "20140721",
"active_numerator_strength": "500"
}Access this data programmatically
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