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
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-288
Product ID 69315-288_e13cbb9d-3850-4f6e-8db1-3e7f1fb23f8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211122
Listing Expiration 2026-12-31
Marketing Start 2022-07-18

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 69315288
Hyphenated Format 69315-288

Supplemental Identifiers

RxCUI
477560 477562
UPC
0369315288054 0369315288092 0369315287095
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 ANDA211122 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (69315-288-05)
  • 90 TABLET in 1 BOTTLE (69315-288-09)
source: ndc

Packages (2)

69315-288-05 500 TABLET in 1 BOTTLE (69315-288-05) 69315-288-09 90 TABLET in 1 BOTTLE (69315-288-09)

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": "e13cbb9d-3850-4f6e-8db1-3e7f1fb23f8a", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0369315288054", "0369315288092", "0369315287095"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["ca09372a-3c75-47c9-80a3-e08dbe243bb4"], "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 in 1 BOTTLE (69315-288-05)", "package_ndc": "69315-288-05", "marketing_start_date": "20220718"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69315-288-09)", "package_ndc": "69315-288-09", "marketing_start_date": "20220718"}], "brand_name": "fenofibrate", "product_id": "69315-288_e13cbb9d-3850-4f6e-8db1-3e7f1fb23f8a", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "69315-288", "generic_name": "fenofibrate", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA211122", "marketing_category": "ANDA", "marketing_start_date": "20220718", "listing_expiration_date": "20261231"}