fenofibrate

Generic: fenofibrate

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-018
Product ID 82868-018_4834f577-f71f-a8da-e063-6294a90a099d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090856
Listing Expiration 2027-12-31
Marketing Start 2023-10-17

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 82868018
Hyphenated Format 82868-018

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 ANDA090856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (82868-018-30)
source: ndc

Packages (1)

82868-018-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-018-30)

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": "4834f577-f71f-a8da-e063-6294a90a099d", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560"], "spl_set_id": ["0865c177-b78a-318e-e063-6394a90a318a"], "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": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-018-30)", "package_ndc": "82868-018-30", "marketing_start_date": "20231017"}], "brand_name": "Fenofibrate", "product_id": "82868-018_4834f577-f71f-a8da-e063-6294a90a099d", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "82868-018", "generic_name": "Fenofibrate", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA090856", "marketing_category": "ANDA", "marketing_start_date": "20231017", "listing_expiration_date": "20271231"}