deferasirox

Generic: deferasirox

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deferasirox
Generic Name deferasirox
Labeler bionpharma inc.
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

deferasirox 500 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-161
Product ID 69452-161_2f9b625f-3835-4481-e063-6394a90a4bf3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210920
Listing Expiration 2026-12-31
Marketing Start 2018-09-28

Pharmacologic Class

Established (EPC)
iron chelator [epc]
Mechanism of Action
iron chelating activity [moa] cytochrome p450 3a4 inducers [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 1a2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452161
Hyphenated Format 69452-161

Supplemental Identifiers

RxCUI
597768 597770 597772
UPC
0369452161135
UNII
V8G4MOF2V9
NUI
N0000000144 N0000175522 N0000185506 N0000187062 N0000182138

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 deferasirox (source: ndc)
Generic Name deferasirox (source: ndc)
Application Number ANDA210920 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 30 TABLET, FOR SUSPENSION in 1 BOTTLE (69452-161-13)
source: ndc

Packages (1)

69452-161-13 30 TABLET, FOR SUSPENSION in 1 BOTTLE (69452-161-13)

Ingredients (1)

deferasirox (500 mg/1)

Linked Drug Pages (1)

Deferasirox ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f9b625f-3835-4481-e063-6394a90a4bf3", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0369452161135"], "unii": ["V8G4MOF2V9"], "rxcui": ["597768", "597770", "597772"], "spl_set_id": ["dc690f20-533e-490e-b13d-143382e02351"], "pharm_class_epc": ["Iron Chelator [EPC]"], "pharm_class_moa": ["Iron Chelating Activity [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (69452-161-13)", "package_ndc": "69452-161-13", "marketing_start_date": "20180928"}], "brand_name": "Deferasirox", "product_id": "69452-161_2f9b625f-3835-4481-e063-6394a90a4bf3", "dosage_form": "TABLET, FOR SUSPENSION", "pharm_class": ["Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Iron Chelating Activity [MoA]", "Iron Chelator [EPC]"], "product_ndc": "69452-161", "generic_name": "deferasirox", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox", "active_ingredients": [{"name": "DEFERASIROX", "strength": "500 mg/1"}], "application_number": "ANDA210920", "marketing_category": "ANDA", "marketing_start_date": "20180928", "listing_expiration_date": "20261231"}