fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler dr. reddy's laboratories limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 130 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-395
Product ID 55111-395_e12ef2fc-f146-a40f-d71c-96a144518d82
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090859
Listing Expiration 2026-12-31
Marketing Start 2014-04-07

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 55111395
Hyphenated Format 55111-395

Supplemental Identifiers

RxCUI
483425 483427
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 ANDA090859 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 130 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (55111-395-01)
  • 30 CAPSULE in 1 BOTTLE (55111-395-30)
  • 90 CAPSULE in 1 BOTTLE (55111-395-90)
source: ndc

Packages (3)

55111-395-01 100 CAPSULE in 1 BOTTLE (55111-395-01) 55111-395-30 30 CAPSULE in 1 BOTTLE (55111-395-30) 55111-395-90 90 CAPSULE in 1 BOTTLE (55111-395-90)

Ingredients (1)

fenofibrate (130 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": "e12ef2fc-f146-a40f-d71c-96a144518d82", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["483425", "483427"], "spl_set_id": ["16ea8ce4-8c1c-4111-509e-86aa688d89a0"], "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 Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (55111-395-01)", "package_ndc": "55111-395-01", "marketing_start_date": "20140407"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (55111-395-30)", "package_ndc": "55111-395-30", "marketing_start_date": "20140407"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (55111-395-90)", "package_ndc": "55111-395-90", "marketing_start_date": "20140407"}], "brand_name": "Fenofibrate", "product_id": "55111-395_e12ef2fc-f146-a40f-d71c-96a144518d82", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "55111-395", "generic_name": "Fenofibrate", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "130 mg/1"}], "application_number": "ANDA090859", "marketing_category": "ANDA", "marketing_start_date": "20140407", "listing_expiration_date": "20261231"}