fenofibrate

Generic: fenofibrate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 200 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-203
Product ID 59651-203_05957860-eab3-4172-9877-455540d0c922
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212232
Listing Expiration 2026-12-31
Marketing Start 2021-09-20

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 59651203
Hyphenated Format 59651-203

Supplemental Identifiers

RxCUI
200311 310288 310289
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

Packaging Origin

Original Packager
true

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 ANDA212232 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-203-01)
source: ndc

Packages (1)

59651-203-01 100 CAPSULE in 1 BOTTLE (59651-203-01)

Ingredients (1)

fenofibrate (200 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": "05957860-eab3-4172-9877-455540d0c922", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["200311", "310288", "310289"], "spl_set_id": ["05957860-eab3-4172-9877-455540d0c922"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59651-203-01)", "package_ndc": "59651-203-01", "marketing_start_date": "20210920"}], "brand_name": "Fenofibrate", "product_id": "59651-203_05957860-eab3-4172-9877-455540d0c922", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "59651-203", "generic_name": "Fenofibrate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "200 mg/1"}], "application_number": "ANDA212232", "marketing_category": "ANDA", "marketing_start_date": "20210920", "listing_expiration_date": "20261231"}