fenofibrate

Generic: fenofibrate

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 54 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-5511
Product ID 60219-5511_cd7dc10f-f401-4e24-8be8-86aa08151ddc
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 602195511
Hyphenated Format 60219-5511

Supplemental Identifiers

RxCUI
349287 351133
UPC
0360219552296 0360219551190
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
  • 90 TABLET in 1 BOTTLE (60219-5511-9)
source: ndc

Packages (1)

60219-5511-9 90 TABLET in 1 BOTTLE (60219-5511-9)

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": "cd7dc10f-f401-4e24-8be8-86aa08151ddc", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0360219552296", "0360219551190"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["65f5dcad-5073-4347-9ec9-e7f350b134c4"], "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 NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (60219-5511-9)", "package_ndc": "60219-5511-9", "marketing_start_date": "20220622"}], "brand_name": "FENOFIBRATE", "product_id": "60219-5511_cd7dc10f-f401-4e24-8be8-86aa08151ddc", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "60219-5511", "generic_name": "FENOFIBRATE", "labeler_name": "Amneal Pharmaceuticals NY 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": "20220622", "listing_expiration_date": "20261231"}