fenofibrate

Generic: fenofibrate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7539
Product ID 0904-7539_9eb677e7-08d9-40a3-b983-21fa58b42296
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213864
Listing Expiration 2026-12-31
Marketing Start 2025-05-22

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 09047539
Hyphenated Format 0904-7539

Supplemental Identifiers

RxCUI
349287
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

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 ANDA213864 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7539-04) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7539-04 30 BLISTER PACK in 1 CARTON (0904-7539-04) / 1 TABLET in 1 BLISTER PACK

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": "9eb677e7-08d9-40a3-b983-21fa58b42296", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["3f4e5db8-5bfb-4b24-8465-9757cbaad2be"], "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": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7539-04)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7539-04", "marketing_start_date": "20250522"}], "brand_name": "FENOFIBRATE", "product_id": "0904-7539_9eb677e7-08d9-40a3-b983-21fa58b42296", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0904-7539", "generic_name": "FENOFIBRATE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA213864", "marketing_category": "ANDA", "marketing_start_date": "20250522", "listing_expiration_date": "20261231"}