fenofibrate

Generic: fenofibrate

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

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

fenofibrate 130 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-131
Product ID 68180-131_00a3d4e3-2364-47fd-919a-f336c12ece0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021695
Listing Expiration 2026-12-31
Marketing Start 2013-02-22

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 68180131
Hyphenated Format 68180-131

Supplemental Identifiers

RxCUI
483425 483427
UPC
0368180131069 0368180130062
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 NDA021695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 130 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (68180-131-06)
source: ndc

Packages (1)

68180-131-06 30 CAPSULE in 1 BOTTLE (68180-131-06)

Ingredients (1)

fenofibrate (130 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": "00a3d4e3-2364-47fd-919a-f336c12ece0d", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368180131069", "0368180130062"], "unii": ["U202363UOS"], "rxcui": ["483425", "483427"], "spl_set_id": ["37b25526-0bd0-4459-a4be-f3a6893506f9"], "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": "30 CAPSULE in 1 BOTTLE (68180-131-06)", "package_ndc": "68180-131-06", "marketing_start_date": "20130222"}], "brand_name": "Fenofibrate", "product_id": "68180-131_00a3d4e3-2364-47fd-919a-f336c12ece0d", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68180-131", "generic_name": "fenofibrate", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "130 mg/1"}], "application_number": "NDA021695", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20130222", "listing_expiration_date": "20261231"}