fenofibrate

Generic: fenofibrate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-949
Product ID 71205-949_7086101a-d52f-43a3-9fc3-70c2aa9487bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207803
Listing Expiration 2026-12-31
Marketing Start 2020-04-23

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 71205949
Hyphenated Format 71205-949

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
  • 30 TABLET, FILM COATED in 1 BOTTLE (71205-949-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71205-949-55)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71205-949-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71205-949-72)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71205-949-78)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71205-949-90)
source: ndc

Packages (6)

71205-949-30 30 TABLET, FILM COATED in 1 BOTTLE (71205-949-30) 71205-949-55 500 TABLET, FILM COATED in 1 BOTTLE (71205-949-55) 71205-949-60 60 TABLET, FILM COATED in 1 BOTTLE (71205-949-60) 71205-949-72 120 TABLET, FILM COATED in 1 BOTTLE (71205-949-72) 71205-949-78 180 TABLET, FILM COATED in 1 BOTTLE (71205-949-78) 71205-949-90 90 TABLET, FILM COATED in 1 BOTTLE (71205-949-90)

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": "7086101a-d52f-43a3-9fc3-70c2aa9487bf", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["41f0f514-1fa9-47a0-a085-a31354842f96"], "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": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71205-949-30)", "package_ndc": "71205-949-30", "marketing_start_date": "20201008"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71205-949-55)", "package_ndc": "71205-949-55", "marketing_start_date": "20201008"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71205-949-60)", "package_ndc": "71205-949-60", "marketing_start_date": "20201008"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71205-949-72)", "package_ndc": "71205-949-72", "marketing_start_date": "20201008"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71205-949-78)", "package_ndc": "71205-949-78", "marketing_start_date": "20201008"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71205-949-90)", "package_ndc": "71205-949-90", "marketing_start_date": "20201008"}], "brand_name": "Fenofibrate", "product_id": "71205-949_7086101a-d52f-43a3-9fc3-70c2aa9487bf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "71205-949", "generic_name": "Fenofibrate", "labeler_name": "Proficient Rx LP", "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": "20200423", "listing_expiration_date": "20261231"}