fenofibrate

Generic: fenofibrate

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler dr. reddy's laboratories inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-910
Product ID 43598-910_f1aa7987-8d7b-4df7-81e1-884966cf0173
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210670
Listing Expiration 2026-12-31
Marketing Start 2020-01-31

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 43598910
Hyphenated Format 43598-910

Supplemental Identifiers

RxCUI
349287 351133
UPC
0343598910901 0343598909905
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 ANDA210670 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (43598-910-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (43598-910-90)
source: ndc

Packages (2)

43598-910-05 500 TABLET, FILM COATED in 1 BOTTLE (43598-910-05) 43598-910-90 90 TABLET, FILM COATED in 1 BOTTLE (43598-910-90)

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": "f1aa7987-8d7b-4df7-81e1-884966cf0173", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0343598910901", "0343598909905"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["9e69d844-5ded-46b6-8321-c420e8b37a63"], "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": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (43598-910-05)", "package_ndc": "43598-910-05", "marketing_start_date": "20200131"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (43598-910-90)", "package_ndc": "43598-910-90", "marketing_start_date": "20200131"}], "brand_name": "Fenofibrate", "product_id": "43598-910_f1aa7987-8d7b-4df7-81e1-884966cf0173", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "43598-910", "generic_name": "FENOFIBRATE", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA210670", "marketing_category": "ANDA", "marketing_start_date": "20200131", "listing_expiration_date": "20261231"}