fenofibrate

Generic: fenofibrate

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler leading pharma, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-290
Product ID 69315-290_34d57f15-8d57-4357-b7fe-e2ffb840359c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210606
Listing Expiration 2026-12-31
Marketing Start 2022-08-20

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 69315290
Hyphenated Format 69315-290

Supplemental Identifiers

RxCUI
349287 351133
UPC
0369315290057
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 ANDA210606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (69315-290-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (69315-290-09)
source: ndc

Packages (2)

69315-290-05 500 TABLET, FILM COATED in 1 BOTTLE (69315-290-05) 69315-290-09 90 TABLET, FILM COATED in 1 BOTTLE (69315-290-09)

Ingredients (1)

fenofibrate (160 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": "34d57f15-8d57-4357-b7fe-e2ffb840359c", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0369315290057"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["f73a40ef-1513-4a07-a5a9-51efb30bf560"], "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": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69315-290-05)", "package_ndc": "69315-290-05", "marketing_start_date": "20220820"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69315-290-09)", "package_ndc": "69315-290-09", "marketing_start_date": "20220820"}], "brand_name": "Fenofibrate", "product_id": "69315-290_34d57f15-8d57-4357-b7fe-e2ffb840359c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "69315-290", "generic_name": "Fenofibrate", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA210606", "marketing_category": "ANDA", "marketing_start_date": "20220820", "listing_expiration_date": "20261231"}