deferasirox oral granules (42806-371)

Drug Facts

Product Profile

Brand Name deferasirox oral granules

Generic Name deferasirox

Labeler epic pharma, llc

Dosage Form GRANULE

Routes

ORAL

Active Ingredients

deferasirox 90 mg/1

Manufacturer

EPIC PHARMA, LLC

Identifiers & Regulatory

Product NDC 42806-371

Product ID 42806-371_2b205859-07ad-1703-e063-6394a90ac140

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214559

Listing Expiration 2026-12-31

Marketing Start 2022-10-06

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 42806371

Hyphenated Format 42806-371

Supplemental Identifiers

RxCUI

1923822 1923826 1923828

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 oral granules (source: ndc)

Generic Name deferasirox (source: ndc)

Application Number ANDA214559 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

90 mg/1

source: ndc

Packaging

30 PACKET in 1 CARTON (42806-371-30) / 1 GRANULE in 1 PACKET

source: ndc

Packages (1)

42806-371-30 30 PACKET in 1 CARTON (42806-371-30) / 1 GRANULE in 1 PACKET

Ingredients (1)

deferasirox (90 mg/1)

Linked Drug Pages (1)

Deferasirox Oral Granules ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2b205859-07ad-1703-e063-6394a90ac140", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "unii": ["V8G4MOF2V9"], "rxcui": ["1923822", "1923826", "1923828"], "spl_set_id": ["7eda83c3-a282-47f6-9f06-d2f9612f5c5b"], "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": ["EPIC PHARMA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (42806-371-30)  / 1 GRANULE in 1 PACKET", "package_ndc": "42806-371-30", "marketing_start_date": "20221006"}], "brand_name": "Deferasirox Oral Granules", "product_id": "42806-371_2b205859-07ad-1703-e063-6394a90ac140", "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": "42806-371", "generic_name": "deferasirox", "labeler_name": "EPIC PHARMA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox Oral Granules", "active_ingredients": [{"name": "DEFERASIROX", "strength": "90 mg/1"}], "application_number": "ANDA214559", "marketing_category": "ANDA", "marketing_start_date": "20221006", "listing_expiration_date": "20261231"}