fenofibrate

Generic: fenofibrate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

fenofibrate 145 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 73190-016
Product ID 73190-016_44ef8586-4869-5684-e063-6394a90a91d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209951
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

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 73190016
Hyphenated Format 73190-016

Supplemental Identifiers

RxCUI
477560 477562
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 ANDA209951 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (73190-016-90)
source: ndc

Packages (1)

73190-016-90 90 TABLET in 1 BOTTLE (73190-016-90)

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": "44ef8586-4869-5684-e063-6394a90a91d5", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["44efa0d1-19d6-9696-e063-6394a90a068d"], "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": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (73190-016-90)", "package_ndc": "73190-016-90", "marketing_start_date": "20251201"}], "brand_name": "Fenofibrate", "product_id": "73190-016_44ef8586-4869-5684-e063-6394a90a91d5", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "73190-016", "generic_name": "Fenofibrate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA209951", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}