deferasirox

Generic: deferasirox

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deferasirox
Generic Name deferasirox
Labeler cipla usa inc.
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

deferasirox 180 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-560
Product ID 69097-560_ce7e02d0-319e-4a5b-87e1-c6550ab4322c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215026
Listing Expiration 2026-12-31
Marketing Start 2022-02-23

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 69097560
Hyphenated Format 69097-560

Supplemental Identifiers

RxCUI
1923822 1923826 1923828
UPC
0369097550530 0369097560539 0369097570538
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 ANDA215026 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (69097-560-53) / 1 GRANULE in 1 PACKET
source: ndc

Packages (1)

69097-560-53 30 PACKET in 1 CARTON (69097-560-53) / 1 GRANULE in 1 PACKET

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": "ce7e02d0-319e-4a5b-87e1-c6550ab4322c", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0369097550530", "0369097560539", "0369097570538"], "unii": ["V8G4MOF2V9"], "rxcui": ["1923822", "1923826", "1923828"], "spl_set_id": ["31c5a91f-e901-418b-a519-779a0c245477"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (69097-560-53)  / 1 GRANULE in 1 PACKET", "package_ndc": "69097-560-53", "marketing_start_date": "20220223"}], "brand_name": "Deferasirox", "product_id": "69097-560_ce7e02d0-319e-4a5b-87e1-c6550ab4322c", "dosage_form": "GRANULE", "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": "69097-560", "generic_name": "Deferasirox", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox", "active_ingredients": [{"name": "DEFERASIROX", "strength": "180 mg/1"}], "application_number": "ANDA215026", "marketing_category": "ANDA", "marketing_start_date": "20220223", "listing_expiration_date": "20261231"}