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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

  • ndc11
    7289300201
    1 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"
}

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