fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler preferred pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8106
Product ID 68788-8106_3953e8ee-89f6-4455-9551-e6bddf5bf6be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204598
Listing Expiration 2026-12-31
Marketing Start 2021-11-03

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 687888106
Hyphenated Format 68788-8106

Supplemental Identifiers

RxCUI
477560
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 ANDA204598 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9)
source: ndc

Packages (4)

68788-8106-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1) 68788-8106-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3) 68788-8106-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6) 68788-8106-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9)

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": "3953e8ee-89f6-4455-9551-e6bddf5bf6be", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560"], "spl_set_id": ["c810b16b-32e2-4d0c-aa28-bf1f62110757"], "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": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8106-1)", "package_ndc": "68788-8106-1", "marketing_start_date": "20211103"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8106-3)", "package_ndc": "68788-8106-3", "marketing_start_date": "20211103"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8106-6)", "package_ndc": "68788-8106-6", "marketing_start_date": "20211103"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8106-9)", "package_ndc": "68788-8106-9", "marketing_start_date": "20211103"}], "brand_name": "Fenofibrate", "product_id": "68788-8106_3953e8ee-89f6-4455-9551-e6bddf5bf6be", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68788-8106", "generic_name": "Fenofibrate", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA204598", "marketing_category": "ANDA", "marketing_start_date": "20211103", "listing_expiration_date": "20261231"}