fenofibrate

Generic: fenofibrate

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 120 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-4391
Product ID 0378-4391_beac0c72-4b03-4b72-9568-db8a22571fe0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204475
Listing Expiration 2026-12-31
Marketing Start 2016-06-23

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 03784391
Hyphenated Format 0378-4391

Supplemental Identifiers

RxCUI
749802 749804
UPC
0303784390771 0303784391778
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 ANDA204475 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (0378-4391-77)
source: ndc

Packages (1)

0378-4391-77 90 TABLET in 1 BOTTLE, PLASTIC (0378-4391-77)

Ingredients (1)

fenofibrate (120 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": "beac0c72-4b03-4b72-9568-db8a22571fe0", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0303784390771", "0303784391778"], "unii": ["U202363UOS"], "rxcui": ["749802", "749804"], "spl_set_id": ["5b67f389-55e8-466b-82bd-5ea992f630aa"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (0378-4391-77)", "package_ndc": "0378-4391-77", "marketing_start_date": "20160623"}], "brand_name": "Fenofibrate", "product_id": "0378-4391_beac0c72-4b03-4b72-9568-db8a22571fe0", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0378-4391", "generic_name": "fenofibrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "120 mg/1"}], "application_number": "ANDA204475", "marketing_category": "ANDA", "marketing_start_date": "20160623", "listing_expiration_date": "20261231"}