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, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 48 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3056
Product ID 50090-3056_ada831fc-d14a-4b44-824f-6e6dac65b073
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204598
Listing Expiration 2027-12-31
Marketing Start 2016-07-14

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 500903056
Hyphenated Format 50090-3056

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 ANDA204598 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-3056-0)
source: ndc

Packages (1)

50090-3056-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-3056-0)

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": "ada831fc-d14a-4b44-824f-6e6dac65b073", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["d9c60b43-dc61-4976-b31f-09c8f8a33138"], "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, FILM COATED in 1 BOTTLE (50090-3056-0)", "package_ndc": "50090-3056-0", "marketing_start_date": "20170614"}], "brand_name": "Fenofibrate", "product_id": "50090-3056_ada831fc-d14a-4b44-824f-6e6dac65b073", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "50090-3056", "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": "ANDA204598", "marketing_category": "ANDA", "marketing_start_date": "20160714", "listing_expiration_date": "20271231"}