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 160 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5854
Product ID 50090-5854_9708cc84-b0b3-4c2d-a255-4c38fb6f5bb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204019
Listing Expiration 2026-12-31
Marketing Start 2020-07-01

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 500905854
Hyphenated Format 50090-5854

Supplemental Identifiers

RxCUI
349287
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 ANDA204019 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-5854-0)
  • 90 TABLET in 1 BOTTLE (50090-5854-1)
source: ndc

Packages (2)

50090-5854-0 30 TABLET in 1 BOTTLE (50090-5854-0) 50090-5854-1 90 TABLET in 1 BOTTLE (50090-5854-1)

Ingredients (1)

fenofibrate (160 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": "9708cc84-b0b3-4c2d-a255-4c38fb6f5bb2", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["00c2f942-e839-46fc-948a-f8e2fa79ccd1"], "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": "30 TABLET in 1 BOTTLE (50090-5854-0)", "package_ndc": "50090-5854-0", "marketing_start_date": "20211111"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-5854-1)", "package_ndc": "50090-5854-1", "marketing_start_date": "20211111"}], "brand_name": "Fenofibrate", "product_id": "50090-5854_9708cc84-b0b3-4c2d-a255-4c38fb6f5bb2", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "50090-5854", "generic_name": "Fenofibrate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA204019", "marketing_category": "ANDA", "marketing_start_date": "20200701", "listing_expiration_date": "20261231"}