fenofibrate

Generic: fenofibrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-389
Product ID 68180-389_e454c5bc-7a0e-4d5e-95fb-ccf812747a3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090856
Listing Expiration 2026-12-31
Marketing Start 2020-08-01

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 68180389
Hyphenated Format 68180-389

Supplemental Identifiers

RxCUI
477560 477562
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 ANDA090856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (68180-389-02)
  • 90 TABLET in 1 BOTTLE (68180-389-09)
source: ndc

Packages (2)

68180-389-02 500 TABLET in 1 BOTTLE (68180-389-02) 68180-389-09 90 TABLET in 1 BOTTLE (68180-389-09)

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": "e454c5bc-7a0e-4d5e-95fb-ccf812747a3c", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["45364845-c3b4-40a1-a677-82202ffaa5ad"], "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": "500 TABLET in 1 BOTTLE (68180-389-02)", "package_ndc": "68180-389-02", "marketing_start_date": "20200801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68180-389-09)", "package_ndc": "68180-389-09", "marketing_start_date": "20200801"}], "brand_name": "Fenofibrate", "product_id": "68180-389_e454c5bc-7a0e-4d5e-95fb-ccf812747a3c", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68180-389", "generic_name": "Fenofibrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA090856", "marketing_category": "ANDA", "marketing_start_date": "20200801", "listing_expiration_date": "20261231"}