deferasirox

Generic: deferasirox

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deferasirox
Generic Name deferasirox
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

deferasirox 360 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-554
Product ID 67877-554_5e8c386f-5879-4f68-bc6f-38041072f5ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210555
Listing Expiration 2026-12-31
Marketing Start 2020-04-01

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 67877554
Hyphenated Format 67877-554

Supplemental Identifiers

RxCUI
1607784 1607792 1607796
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 ANDA210555 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-554-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-554-90)
source: ndc

Packages (2)

67877-554-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-554-30) 67877-554-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-554-90)

Ingredients (1)

deferasirox (360 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": "5e8c386f-5879-4f68-bc6f-38041072f5ad", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "unii": ["V8G4MOF2V9"], "rxcui": ["1607784", "1607792", "1607796"], "spl_set_id": ["0fb210b3-6a3d-4313-83ce-52012e384f9b"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-554-30)", "package_ndc": "67877-554-30", "marketing_start_date": "20200401"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-554-90)", "package_ndc": "67877-554-90", "marketing_start_date": "20200401"}], "brand_name": "Deferasirox", "product_id": "67877-554_5e8c386f-5879-4f68-bc6f-38041072f5ad", "dosage_form": "TABLET, FILM COATED", "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": "67877-554", "generic_name": "Deferasirox", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox", "active_ingredients": [{"name": "DEFERASIROX", "strength": "360 mg/1"}], "application_number": "ANDA210555", "marketing_category": "ANDA", "marketing_start_date": "20200401", "listing_expiration_date": "20261231"}