deferasirox

Generic: deferasirox

Labeler: msn laboratories private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deferasirox
Generic Name deferasirox
Labeler msn laboratories private limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

deferasirox 360 mg/1

Manufacturer
MSN LABORATORIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 69539-075
Product ID 69539-075_da168049-e499-4563-afe8-82ae754ed640
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210945
Listing Expiration 2026-12-31
Marketing Start 2019-11-20

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 69539075
Hyphenated Format 69539-075

Supplemental Identifiers

RxCUI
1607784 1607792 1607796
UPC
0369539074303 0369539075997 0369539074990 0369539073993 0369539075300 0369539073306
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 ANDA210945 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 360 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69539-075-30)
  • 1000 TABLET in 1 BOTTLE (69539-075-99)
source: ndc

Packages (2)

69539-075-30 30 TABLET in 1 BOTTLE (69539-075-30) 69539-075-99 1000 TABLET in 1 BOTTLE (69539-075-99)

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": "da168049-e499-4563-afe8-82ae754ed640", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0369539074303", "0369539075997", "0369539074990", "0369539073993", "0369539075300", "0369539073306"], "unii": ["V8G4MOF2V9"], "rxcui": ["1607784", "1607792", "1607796"], "spl_set_id": ["0354cbc7-9b32-4513-976a-2ef2da39b6b3"], "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": ["MSN LABORATORIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69539-075-30)", "package_ndc": "69539-075-30", "marketing_start_date": "20191120"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (69539-075-99)", "package_ndc": "69539-075-99", "marketing_start_date": "20191120"}], "brand_name": "Deferasirox", "product_id": "69539-075_da168049-e499-4563-afe8-82ae754ed640", "dosage_form": "TABLET", "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": "69539-075", "generic_name": "Deferasirox", "labeler_name": "MSN LABORATORIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox", "active_ingredients": [{"name": "DEFERASIROX", "strength": "360 mg/1"}], "application_number": "ANDA210945", "marketing_category": "ANDA", "marketing_start_date": "20191120", "listing_expiration_date": "20261231"}