fenofibrate

Generic: fenofibrate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 54 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-5511
Product ID 0115-5511_71bb776c-1208-4049-bba2-0f9eb1ea4efe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076509
Listing Expiration 2026-12-31
Marketing Start 2010-02-01

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 01155511
Hyphenated Format 0115-5511

Supplemental Identifiers

RxCUI
349287 351133
UPC
0301155522103
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 ANDA076509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0115-5511-01)
  • 500 TABLET in 1 BOTTLE (0115-5511-02)
  • 1000 TABLET in 1 BOTTLE (0115-5511-03)
  • 90 TABLET in 1 BOTTLE (0115-5511-10)
source: ndc

Packages (4)

0115-5511-01 100 TABLET in 1 BOTTLE (0115-5511-01) 0115-5511-02 500 TABLET in 1 BOTTLE (0115-5511-02) 0115-5511-03 1000 TABLET in 1 BOTTLE (0115-5511-03) 0115-5511-10 90 TABLET in 1 BOTTLE (0115-5511-10)

Ingredients (1)

fenofibrate (54 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": "71bb776c-1208-4049-bba2-0f9eb1ea4efe", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0301155522103"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["fa08cf6a-d306-4979-9b23-ac7febf4fd12"], "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": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0115-5511-01)", "package_ndc": "0115-5511-01", "marketing_start_date": "20100201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0115-5511-02)", "package_ndc": "0115-5511-02", "marketing_start_date": "20100201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (0115-5511-03)", "package_ndc": "0115-5511-03", "marketing_start_date": "20100201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (0115-5511-10)", "package_ndc": "0115-5511-10", "marketing_start_date": "20100201"}], "brand_name": "FENOFIBRATE", "product_id": "0115-5511_71bb776c-1208-4049-bba2-0f9eb1ea4efe", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0115-5511", "generic_name": "FENOFIBRATE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA076509", "marketing_category": "ANDA", "marketing_start_date": "20100201", "listing_expiration_date": "20261231"}