deferasirox oral

Generic: deferasirox oral

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name deferasirox oral
Generic Name deferasirox oral
Labeler ascend laboratories, llc
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

deferasirox 180 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-676
Product ID 67877-676_65865f16-a960-4a42-b0b6-05ab2885bf41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213374
Listing Expiration 2026-12-31
Marketing Start 2020-07-16

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 67877676
Hyphenated Format 67877-676

Supplemental Identifiers

RxCUI
1923822 1923826 1923828
UPC
0367877675718 0367877677736 0367877676722
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 (source: ndc)
Generic Name deferasirox oral (source: ndc)
Application Number ANDA213374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (67877-676-84) / 1 GRANULE in 1 PACKET (67877-676-72)
source: ndc

Packages (1)

67877-676-84 30 PACKET in 1 CARTON (67877-676-84) / 1 GRANULE in 1 PACKET (67877-676-72)

Ingredients (1)

deferasirox (180 mg/1)

Linked Drug Pages (1)

Deferasirox oral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "65865f16-a960-4a42-b0b6-05ab2885bf41", "openfda": {"nui": ["N0000000144", "N0000175522", "N0000185506", "N0000187062", "N0000182138"], "upc": ["0367877675718", "0367877677736", "0367877676722"], "unii": ["V8G4MOF2V9"], "rxcui": ["1923822", "1923826", "1923828"], "spl_set_id": ["2c2842a0-7781-4047-84cd-88bd018e10c7"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (67877-676-84)  / 1 GRANULE in 1 PACKET (67877-676-72)", "package_ndc": "67877-676-84", "marketing_start_date": "20200716"}], "brand_name": "Deferasirox oral", "product_id": "67877-676_65865f16-a960-4a42-b0b6-05ab2885bf41", "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": "67877-676", "generic_name": "Deferasirox oral", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Deferasirox oral", "active_ingredients": [{"name": "DEFERASIROX", "strength": "180 mg/1"}], "application_number": "ANDA213374", "marketing_category": "ANDA", "marketing_start_date": "20200716", "listing_expiration_date": "20261231"}