exjade

Generic: deferasirox

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name exjade
Generic Name deferasirox
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

deferasirox 125 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0468
Product ID 0078-0468_17c39217-5502-420d-8d2e-799626756189
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021882
Listing Expiration 2027-12-31
Marketing Start 2005-11-30

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 00780468
Hyphenated Format 0078-0468

Supplemental Identifiers

RxCUI
597768 597770 597772 616159 616161 616163
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 exjade (source: ndc)
Generic Name deferasirox (source: ndc)
Application Number NDA021882 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)
source: ndc

Packages (1)

0078-0468-15 30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)

Ingredients (1)

deferasirox (125 mg/1)

Linked Drug Pages (1)

Exjade ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "17c39217-5502-420d-8d2e-799626756189", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "unii": ["V8G4MOF2V9"], "rxcui": ["597768", "597770", "597772", "616159", "616161", "616163"], "spl_set_id": ["3495a70c-870c-4968-940e-8baea152cf85"], "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": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)", "package_ndc": "0078-0468-15", "marketing_start_date": "20051130"}], "brand_name": "Exjade", "product_id": "0078-0468_17c39217-5502-420d-8d2e-799626756189", "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": "0078-0468", "generic_name": "deferasirox", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Exjade", "active_ingredients": [{"name": "DEFERASIROX", "strength": "125 mg/1"}], "application_number": "NDA021882", "marketing_category": "NDA", "marketing_start_date": "20051130", "listing_expiration_date": "20271231"}