fenofibrate

Generic: fenofibrate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-410
Product ID 72789-410_324713a3-9b23-55ea-e063-6394a90abaab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076509
Listing Expiration 2026-12-31
Marketing Start 2022-06-22

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 72789410
Hyphenated Format 72789-410

Supplemental Identifiers

RxCUI
349287
UPC
0372789410302
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 ANDA076509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-410-30)
source: ndc

Packages (1)

72789-410-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-410-30)

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": "324713a3-9b23-55ea-e063-6394a90abaab", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0372789410302"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["35ba17d9-0dd7-4f15-8f74-be5fd15f1917"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-410-30)", "package_ndc": "72789-410-30", "marketing_start_date": "20240605"}], "brand_name": "FENOFIBRATE", "product_id": "72789-410_324713a3-9b23-55ea-e063-6394a90abaab", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "72789-410", "generic_name": "FENOFIBRATE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA076509", "marketing_category": "ANDA", "marketing_start_date": "20220622", "listing_expiration_date": "20261231"}