fenofibrate

Generic: fenofibrate

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler coupler llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 67 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1538
Product ID 67046-1538_3134b1f0-2cc0-d83e-e063-6394a90a171d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209504
Listing Expiration 2026-12-31
Marketing Start 2025-03-25

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 670461538
Hyphenated Format 67046-1538

Supplemental Identifiers

RxCUI
200311
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 ANDA209504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 67 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (67046-1538-3)
source: ndc

Packages (1)

67046-1538-3 30 CAPSULE in 1 BLISTER PACK (67046-1538-3)

Ingredients (1)

fenofibrate (67 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": "3134b1f0-2cc0-d83e-e063-6394a90a171d", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["200311"], "spl_set_id": ["3134b274-5dc0-cf90-e063-6294a90a252b"], "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": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1538-3)", "package_ndc": "67046-1538-3", "marketing_start_date": "20250325"}], "brand_name": "Fenofibrate", "product_id": "67046-1538_3134b1f0-2cc0-d83e-e063-6394a90a171d", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "67046-1538", "generic_name": "Fenofibrate", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "67 mg/1"}], "application_number": "ANDA209504", "marketing_category": "ANDA", "marketing_start_date": "20250325", "listing_expiration_date": "20261231"}