DEFERASIROX

Generic: DEFERASIROX

Labeler: Sun Pharmaceutical Industries, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name DEFERASIROX
Generic Name DEFERASIROX
Labeler Sun Pharmaceutical Industries, Inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

DEFERASIROX 90 mg/1

Identifiers & Regulatory

Product NDC 57664-768
Product ID 57664-768_230376c1-a7e2-cdce-e063-6394a90a8af7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211641
Listing Expiration 2026-12-31
Marketing Start 2020-01-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57664768
Hyphenated Format 57664-768

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 ANDA211641 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (57664-768-83)
source: ndc

Packages (1)

57664-768-83 30 TABLET, FILM COATED in 1 BOTTLE (57664-768-83)

Ingredients (1)

DEFERASIROX (90 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": "230376c1-a7e2-cdce-e063-6394a90a8af7", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0357664768839", "0357664770832", "0357664769836"], "unii": ["V8G4MOF2V9"], "rxcui": ["1607784", "1607792", "1607796"], "spl_set_id": ["53e645f5-3b29-4c9c-a620-b14f85be5ad4"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (57664-768-83)", "package_ndc": "57664-768-83", "marketing_start_date": "20200102"}], "brand_name": "DEFERASIROX", "product_id": "57664-768_230376c1-a7e2-cdce-e063-6394a90a8af7", "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": "57664-768", "generic_name": "DEFERASIROX", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEFERASIROX", "active_ingredients": [{"name": "DEFERASIROX", "strength": "90 mg/1"}], "application_number": "ANDA211641", "marketing_category": "ANDA", "marketing_start_date": "20200102", "listing_expiration_date": "20261231"}