fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

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

fenofibrate 160 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3542
Product ID 68071-3542_2d3fb146-e3be-92bf-e063-6394a90a1b3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216798
Listing Expiration 2026-12-31
Marketing Start 2022-09-27

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 680713542
Hyphenated Format 68071-3542

Supplemental Identifiers

RxCUI
349287
UPC
0368071354294
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 ANDA216798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-3542-9)
source: ndc

Packages (1)

68071-3542-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-3542-9)

Ingredients (1)

fenofibrate (160 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": "2d3fb146-e3be-92bf-e063-6394a90a1b3a", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368071354294"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["0b4e90dd-646b-afec-e063-6294a90a598e"], "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": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3542-9)", "package_ndc": "68071-3542-9", "marketing_start_date": "20231129"}], "brand_name": "Fenofibrate", "product_id": "68071-3542_2d3fb146-e3be-92bf-e063-6394a90a1b3a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68071-3542", "generic_name": "Fenofibrate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA216798", "marketing_category": "ANDA", "marketing_start_date": "20220927", "listing_expiration_date": "20261231"}