fenofibrate

Generic: fenofibrate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-340
Product ID 33342-340_ab7aad70-2879-4260-831e-cbfbe8be73b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210248
Listing Expiration 2026-12-31
Marketing Start 2024-11-13

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 33342340
Hyphenated Format 33342-340

Supplemental Identifiers

RxCUI
477560 477562
UPC
0333342339157 0333342340108
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 ANDA210248 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (33342-340-07)
  • 90 TABLET in 1 BOTTLE (33342-340-10)
  • 10 BLISTER PACK in 1 CARTON (33342-340-12) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (33342-340-15)
source: ndc

Packages (4)

33342-340-07 30 TABLET in 1 BOTTLE (33342-340-07) 33342-340-10 90 TABLET in 1 BOTTLE (33342-340-10) 33342-340-12 10 BLISTER PACK in 1 CARTON (33342-340-12) / 10 TABLET in 1 BLISTER PACK 33342-340-15 500 TABLET in 1 BOTTLE (33342-340-15)

Ingredients (1)

fenofibrate (145 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": "ab7aad70-2879-4260-831e-cbfbe8be73b2", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0333342339157", "0333342340108"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["e8b9d1f5-0541-424f-b1d4-bef6381aa934"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (33342-340-07)", "package_ndc": "33342-340-07", "marketing_start_date": "20241113"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (33342-340-10)", "package_ndc": "33342-340-10", "marketing_start_date": "20241113"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-340-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-340-12", "marketing_start_date": "20241113"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (33342-340-15)", "package_ndc": "33342-340-15", "marketing_start_date": "20241113"}], "brand_name": "Fenofibrate", "product_id": "33342-340_ab7aad70-2879-4260-831e-cbfbe8be73b2", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "33342-340", "generic_name": "Fenofibrate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA210248", "marketing_category": "ANDA", "marketing_start_date": "20241113", "listing_expiration_date": "20261231"}