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, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3066
Product ID 0378-3066_5683e52e-e8f1-47ab-a77b-ade2abe12c07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202856
Listing Expiration 2026-12-31
Marketing Start 2013-05-14

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 03783066
Hyphenated Format 0378-3066

Supplemental Identifiers

RxCUI
477560 477562
UPC
0303783066776 0303783065779
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 ANDA202856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-77)
source: ndc

Packages (2)

0378-3066-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-05) 0378-3066-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-77)

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": "5683e52e-e8f1-47ab-a77b-ade2abe12c07", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0303783066776", "0303783065779"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["0f958942-1504-40a1-8ad8-43df2c3f717e"], "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": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-05)", "package_ndc": "0378-3066-05", "marketing_start_date": "20130514"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3066-77)", "package_ndc": "0378-3066-77", "marketing_start_date": "20130514"}], "brand_name": "Fenofibrate", "product_id": "0378-3066_5683e52e-e8f1-47ab-a77b-ade2abe12c07", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0378-3066", "generic_name": "fenofibrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA202856", "marketing_category": "ANDA", "marketing_start_date": "20130514", "listing_expiration_date": "20261231"}