beleodaq

Generic: belinostat

Labeler: acrotech biopharma inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name beleodaq
Generic Name belinostat
Labeler acrotech biopharma inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

belinostat 500 mg/10mL

Manufacturer
Acrotech Biopharma Inc

Identifiers & Regulatory

Product NDC 72893-002
Product ID 72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206256
Listing Expiration 2026-12-31
Marketing Start 2014-07-21

Pharmacologic Class

Established (EPC)
histone deacetylase inhibitor [epc]
Mechanism of Action
histone deacetylase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72893002
Hyphenated Format 72893-002

Supplemental Identifiers

RxCUI
1543547 1543552
UPC
0372893002011
UNII
F4H96P17NZ
NUI
N0000175588 N0000175071

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name beleodaq (source: ndc)
Generic Name belinostat (source: ndc)
Application Number NDA206256 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL
source: ndc

Packages (1)

72893-002-01 1 VIAL in 1 CARTON (72893-002-01) / 10 mL in 1 VIAL

Ingredients (1)

belinostat (500 mg/10mL)

Linked Drug Pages (1)

Beleodaq ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0af69daf-c3eb-436a-b8d9-8ae89c5f0c85", "openfda": {"nui": ["N0000175588", "N0000175071"], "upc": ["0372893002011"], "unii": ["F4H96P17NZ"], "rxcui": ["1543547", "1543552"], "spl_set_id": ["2e8ef36b-71fa-4492-a16f-577d5f7d111d"], "pharm_class_epc": ["Histone Deacetylase Inhibitor [EPC]"], "pharm_class_moa": ["Histone Deacetylase Inhibitors [MoA]"], "manufacturer_name": ["Acrotech Biopharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (72893-002-01)  / 10 mL in 1 VIAL", "package_ndc": "72893-002-01", "marketing_start_date": "20140721"}], "brand_name": "Beleodaq", "product_id": "72893-002_0af69daf-c3eb-436a-b8d9-8ae89c5f0c85", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Histone Deacetylase Inhibitor [EPC]", "Histone Deacetylase Inhibitors [MoA]"], "product_ndc": "72893-002", "generic_name": "Belinostat", "labeler_name": "Acrotech Biopharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Beleodaq", "active_ingredients": [{"name": "BELINOSTAT", "strength": "500 mg/10mL"}], "application_number": "NDA206256", "marketing_category": "NDA", "marketing_start_date": "20140721", "listing_expiration_date": "20261231"}