fenofibrate

Generic: fenofibrate

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler mylan institutional inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 48 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-599
Product ID 51079-599_3ac22e61-98d2-068c-e063-6394a90ae338
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202856
Listing Expiration 2026-12-31
Marketing Start 2013-06-10

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 51079599
Hyphenated Format 51079-599

Supplemental Identifiers

RxCUI
477560 477562
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

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 ANDA202856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-599-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-599-01)
source: ndc

Packages (1)

51079-599-20 100 BLISTER PACK in 1 CARTON (51079-599-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-599-01)

Ingredients (1)

fenofibrate (48 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": "3ac22e61-98d2-068c-e063-6394a90ae338", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["5a90e0a4-7892-462f-9776-037d23a93b10"], "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": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-599-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-599-01)", "package_ndc": "51079-599-20", "marketing_start_date": "20130610"}], "brand_name": "Fenofibrate", "product_id": "51079-599_3ac22e61-98d2-068c-e063-6394a90ae338", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "51079-599", "generic_name": "fenofibrate", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "48 mg/1"}], "application_number": "ANDA202856", "marketing_category": "ANDA", "marketing_start_date": "20130610", "listing_expiration_date": "20261231"}