deferasirox

Generic: deferasirox

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deferasirox
Generic Name deferasirox
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

deferasirox 125 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-324
Product ID 46708-324_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210060
Listing Expiration 2026-12-31
Marketing Start 2019-11-21

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 46708324
Hyphenated Format 46708-324

Supplemental Identifiers

RxCUI
597768 597770 597772
UPC
0346708326302 0346708325305
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 ANDA210060 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30)
source: ndc

Packages (1)

46708-324-30 30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30)

Ingredients (1)

deferasirox (125 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": "3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0346708326302", "0346708325305"], "unii": ["V8G4MOF2V9"], "rxcui": ["597768", "597770", "597772"], "spl_set_id": ["8c8b84f3-6887-4485-b5e0-03f254b88a15"], "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": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30)", "package_ndc": "46708-324-30", "marketing_start_date": "20191121"}], "brand_name": "Deferasirox", "product_id": "46708-324_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80", "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": "46708-324", "generic_name": "Deferasirox", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox", "active_ingredients": [{"name": "DEFERASIROX", "strength": "125 mg/1"}], "application_number": "ANDA210060", "marketing_category": "ANDA", "marketing_start_date": "20191121", "listing_expiration_date": "20261231"}