fenofibrate

Generic: fenofibrate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-427
Product ID 42291-427_485d31e4-a2a8-8165-e063-6294a90a14fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207803
Listing Expiration 2027-12-31
Marketing Start 2023-03-08

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 42291427
Hyphenated Format 42291-427

Supplemental Identifiers

RxCUI
349287
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 ANDA207803 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (42291-427-50)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42291-427-90)
source: ndc

Packages (2)

42291-427-50 500 TABLET, FILM COATED in 1 BOTTLE (42291-427-50) 42291-427-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-427-90)

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": "485d31e4-a2a8-8165-e063-6294a90a14fc", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["f669f231-98b9-5014-e053-2a95a90a4e4c"], "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": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42291-427-50)", "package_ndc": "42291-427-50", "marketing_start_date": "20230308"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42291-427-90)", "package_ndc": "42291-427-90", "marketing_start_date": "20230308"}], "brand_name": "Fenofibrate", "product_id": "42291-427_485d31e4-a2a8-8165-e063-6294a90a14fc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "42291-427", "generic_name": "Fenofibrate", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA207803", "marketing_category": "ANDA", "marketing_start_date": "20230308", "listing_expiration_date": "20271231"}