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
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-190
Product ID 71205-190_27025f51-5dff-4994-aab0-310895239337
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210138
Listing Expiration 2026-12-31
Marketing Start 2018-07-20

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 71205190
Hyphenated Format 71205-190

Supplemental Identifiers

RxCUI
349287
UPC
0371205190903
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 ANDA210138 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (71205-190-30)
  • 60 TABLET in 1 BOTTLE (71205-190-60)
  • 90 TABLET in 1 BOTTLE (71205-190-90)
source: ndc

Packages (3)

71205-190-30 30 TABLET in 1 BOTTLE (71205-190-30) 71205-190-60 60 TABLET in 1 BOTTLE (71205-190-60) 71205-190-90 90 TABLET in 1 BOTTLE (71205-190-90)

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": "27025f51-5dff-4994-aab0-310895239337", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0371205190903"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["b9a6866c-9dbe-4419-bcad-52ec0127821f"], "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 in 1 BOTTLE (71205-190-30)", "package_ndc": "71205-190-30", "marketing_start_date": "20190101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-190-60)", "package_ndc": "71205-190-60", "marketing_start_date": "20190101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-190-90)", "package_ndc": "71205-190-90", "marketing_start_date": "20190101"}], "brand_name": "fenofibrate", "product_id": "71205-190_27025f51-5dff-4994-aab0-310895239337", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "71205-190", "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": "ANDA210138", "marketing_category": "ANDA", "marketing_start_date": "20180720", "listing_expiration_date": "20261231"}