lipofen

Generic: fenofibrate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lipofen
Generic Name fenofibrate
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 50 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 62559-305
Product ID 62559-305_52430d63-6866-481c-a1b3-e411809cadfd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021612
Listing Expiration 2026-12-31
Marketing Start 2021-09-24

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 62559305
Hyphenated Format 62559-305

Supplemental Identifiers

RxCUI
616852 616853 702055 702169
UPC
0362559306904 0362559305907
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 lipofen (source: ndc)
Generic Name fenofibrate (source: ndc)
Application Number NDA021612 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (62559-305-90)
source: ndc

Packages (1)

62559-305-90 90 CAPSULE in 1 BOTTLE (62559-305-90)

Ingredients (1)

fenofibrate (50 mg/1)

Linked Drug Pages (1)

Lipofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "52430d63-6866-481c-a1b3-e411809cadfd", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0362559306904", "0362559305907"], "unii": ["U202363UOS"], "rxcui": ["616852", "616853", "702055", "702169"], "spl_set_id": ["78b789b9-854f-46b9-97f3-a48759a6ff89"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62559-305-90)", "package_ndc": "62559-305-90", "marketing_start_date": "20210924"}], "brand_name": "Lipofen", "product_id": "62559-305_52430d63-6866-481c-a1b3-e411809cadfd", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "62559-305", "generic_name": "fenofibrate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lipofen", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "50 mg/1"}], "application_number": "NDA021612", "marketing_category": "NDA", "marketing_start_date": "20210924", "listing_expiration_date": "20261231"}