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, FILM COATED
Routes
ORAL
Active Ingredients

deferasirox 180 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-411
Product ID 46708-411_d58c204e-f996-4969-85c7-3fbe078bf6a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211824
Listing Expiration 2026-12-31
Marketing Start 2020-06-15

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 46708411
Hyphenated Format 46708-411

Supplemental Identifiers

RxCUI
1607784 1607792 1607796
UPC
0346708411305 0346708412302 0346708410308
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 ANDA211824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-411-30)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-411-91)
source: ndc

Packages (2)

46708-411-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-411-30) 46708-411-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-411-91)

Ingredients (1)

deferasirox (180 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": "d58c204e-f996-4969-85c7-3fbe078bf6a8", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0346708411305", "0346708412302", "0346708410308"], "unii": ["V8G4MOF2V9"], "rxcui": ["1607784", "1607792", "1607796"], "spl_set_id": ["dd9450f4-7c95-4322-8806-9820570f5aa2"], "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, FILM COATED in 1 BOTTLE (46708-411-30)", "package_ndc": "46708-411-30", "marketing_start_date": "20200615"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-411-91)", "package_ndc": "46708-411-91", "marketing_start_date": "20200615"}], "brand_name": "DEFERASIROX", "product_id": "46708-411_d58c204e-f996-4969-85c7-3fbe078bf6a8", "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": "46708-411", "generic_name": "DEFERASIROX", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEFERASIROX", "active_ingredients": [{"name": "DEFERASIROX", "strength": "180 mg/1"}], "application_number": "ANDA211824", "marketing_category": "ANDA", "marketing_start_date": "20200615", "listing_expiration_date": "20261231"}