fenofibrate

Generic: fenofibrate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler aurobindo pharma limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-769
Product ID 65862-769_05013562-2f49-4b1f-a8eb-5925f3d3bead
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205118
Listing Expiration 2026-12-31
Marketing Start 2016-05-05

Pharmacologic Class

Established (EPC)
peroxisome proliferator receptor alpha agonist [epc]
Mechanism of Action
peroxisome proliferator-activated receptor alpha agonists [moa]
Chemical Structure
fibric acids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862769
Hyphenated Format 65862-769

Supplemental Identifiers

RxCUI
477560 477562
UPC
0365862768902
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

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 fenofibrate (source: ndc)
Generic Name fenofibrate (source: ndc)
Application Number ANDA205118 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 100 TABLET, COATED in 1 BOTTLE (65862-769-01)
  • 500 TABLET, COATED in 1 BOTTLE (65862-769-05)
  • 10 BLISTER PACK in 1 CARTON (65862-769-78) / 10 TABLET, COATED in 1 BLISTER PACK (65862-769-10)
  • 90 TABLET, COATED in 1 BOTTLE (65862-769-90)
  • 1000 TABLET, COATED in 1 BOTTLE (65862-769-99)
source: ndc

Packages (5)

65862-769-01 100 TABLET, COATED in 1 BOTTLE (65862-769-01) 65862-769-05 500 TABLET, COATED in 1 BOTTLE (65862-769-05) 65862-769-78 10 BLISTER PACK in 1 CARTON (65862-769-78) / 10 TABLET, COATED in 1 BLISTER PACK (65862-769-10) 65862-769-90 90 TABLET, COATED in 1 BOTTLE (65862-769-90) 65862-769-99 1000 TABLET, COATED in 1 BOTTLE (65862-769-99)

Ingredients (1)

fenofibrate (145 mg/1)

Linked Drug Pages (1)

Fenofibrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "05013562-2f49-4b1f-a8eb-5925f3d3bead", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0365862768902"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["84fcea7a-05ed-44c2-98fa-7e87b28d2261"], "pharm_class_cs": ["Fibric Acids [CS]"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "pharm_class_moa": ["Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (65862-769-01)", "package_ndc": "65862-769-01", "marketing_start_date": "20160505"}, {"sample": false, "description": "500 TABLET, COATED in 1 BOTTLE (65862-769-05)", "package_ndc": "65862-769-05", "marketing_start_date": "20160505"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-769-78)  / 10 TABLET, COATED in 1 BLISTER PACK (65862-769-10)", "package_ndc": "65862-769-78", "marketing_start_date": "20160505"}, {"sample": false, "description": "90 TABLET, COATED in 1 BOTTLE (65862-769-90)", "package_ndc": "65862-769-90", "marketing_start_date": "20160505"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (65862-769-99)", "package_ndc": "65862-769-99", "marketing_start_date": "20160505"}], "brand_name": "Fenofibrate", "product_id": "65862-769_05013562-2f49-4b1f-a8eb-5925f3d3bead", "dosage_form": "TABLET, COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "65862-769", "generic_name": "Fenofibrate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA205118", "marketing_category": "ANDA", "marketing_start_date": "20160505", "listing_expiration_date": "20261231"}