fenofibrate

Generic: fenofibrate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 48 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5327
Product ID 50090-5327_107dcbf9-9c02-41fe-859d-e9b418b62d3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208709
Listing Expiration 2026-12-31
Marketing Start 2016-12-15

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 500905327
Hyphenated Format 50090-5327

Supplemental Identifiers

RxCUI
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 ANDA208709 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (50090-5327-0)
source: ndc

Packages (1)

50090-5327-0 90 TABLET in 1 BOTTLE (50090-5327-0)

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": "107dcbf9-9c02-41fe-859d-e9b418b62d3c", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477562"], "spl_set_id": ["734f72a2-96f7-4480-9a87-c1ffd94b5f0b"], "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": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-5327-0)", "package_ndc": "50090-5327-0", "marketing_start_date": "20201030"}], "brand_name": "FENOFIBRATE", "product_id": "50090-5327_107dcbf9-9c02-41fe-859d-e9b418b62d3c", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "50090-5327", "generic_name": "FENOFIBRATE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "48 mg/1"}], "application_number": "ANDA208709", "marketing_category": "ANDA", "marketing_start_date": "20161215", "listing_expiration_date": "20261231"}