fenofibrate

Generic: fenofibrate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 54 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-312
Product ID 50268-312_43bf4291-a298-f2fe-e063-6394a90a8fb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076509
Listing Expiration 2026-12-31
Marketing Start 2015-08-13

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 50268312
Hyphenated Format 50268-312

Supplemental Identifiers

RxCUI
349287 351133
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 ANDA076509 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-312-15) / 1 TABLET in 1 BLISTER PACK (50268-312-11)
source: ndc

Packages (1)

50268-312-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-312-15) / 1 TABLET in 1 BLISTER PACK (50268-312-11)

Ingredients (1)

fenofibrate (54 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": "43bf4291-a298-f2fe-e063-6394a90a8fb3", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["d4e1d692-3c03-7406-ee06-7a6fb39ed3e7"], "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": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-312-15)  / 1 TABLET in 1 BLISTER PACK (50268-312-11)", "package_ndc": "50268-312-15", "marketing_start_date": "20150813"}], "brand_name": "FENOFIBRATE", "product_id": "50268-312_43bf4291-a298-f2fe-e063-6394a90a8fb3", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "50268-312", "generic_name": "FENOFIBRATE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA076509", "marketing_category": "ANDA", "marketing_start_date": "20150813", "listing_expiration_date": "20261231"}