fenofibrate
Generic: fenofibrate
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
fenofibrate
Generic Name
fenofibrate
Labeler
lupin pharmaceuticals, inc.
Dosage Form
TABLET
Routes
Active Ingredients
fenofibrate 54 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68180-231
Product ID
68180-231_a70e38c8-07c1-4df6-8c2b-b5e0df3c304d
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA204019
Listing Expiration
2026-12-31
Marketing Start
2020-07-01
Pharmacologic Class
Established (EPC)
Mechanism of Action
Chemical Structure
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68180231
Hyphenated Format
68180-231
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
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
ANDA204019 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 54 mg/1
Packaging
- 90 TABLET in 1 BOTTLE (68180-231-09)
Packages (1)
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "a70e38c8-07c1-4df6-8c2b-b5e0df3c304d", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368180232094", "0368180231097"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["4cb6617c-f787-470f-81d8-0aba46df937f"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68180-231-09)", "package_ndc": "68180-231-09", "marketing_start_date": "20200701"}], "brand_name": "Fenofibrate", "product_id": "68180-231_a70e38c8-07c1-4df6-8c2b-b5e0df3c304d", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68180-231", "generic_name": "Fenofibrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA204019", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}