fenofibrate

Generic: fenofibrate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 43 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3120
Product ID 60505-3120_81d94e71-5260-d81d-f3b9-070ec3c0743a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202252
Listing Expiration 2026-12-31
Marketing Start 2013-07-26

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 605053120
Hyphenated Format 60505-3120

Supplemental Identifiers

RxCUI
483425 483427
UPC
0360505312139 0360505312030
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 ANDA202252 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 43 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (60505-3120-1)
  • 30 CAPSULE in 1 BOTTLE (60505-3120-3)
source: ndc

Packages (2)

60505-3120-1 100 CAPSULE in 1 BOTTLE (60505-3120-1) 60505-3120-3 30 CAPSULE in 1 BOTTLE (60505-3120-3)

Ingredients (1)

fenofibrate (43 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": "81d94e71-5260-d81d-f3b9-070ec3c0743a", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0360505312139", "0360505312030"], "unii": ["U202363UOS"], "rxcui": ["483425", "483427"], "spl_set_id": ["68024459-987a-9cf4-f539-4959093bc9f0"], "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": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (60505-3120-1)", "package_ndc": "60505-3120-1", "marketing_start_date": "20130726"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (60505-3120-3)", "package_ndc": "60505-3120-3", "marketing_start_date": "20130726"}], "brand_name": "Fenofibrate", "product_id": "60505-3120_81d94e71-5260-d81d-f3b9-070ec3c0743a", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "60505-3120", "generic_name": "Fenofibrate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "43 mg/1"}], "application_number": "ANDA202252", "marketing_category": "ANDA", "marketing_start_date": "20130726", "listing_expiration_date": "20261231"}