fenofibrate

Generic: fenofibrate

Labeler: rhodes pharmaceuticals l.p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler rhodes pharmaceuticals l.p.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 54 mg/1

Manufacturer
Rhodes Pharmaceuticals L.P.

Identifiers & Regulatory

Product NDC 42858-454
Product ID 42858-454_2ee176e8-44de-4206-a71a-d0cbacdc0a81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076433
Listing Expiration 2026-12-31
Marketing Start 2017-06-01

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 42858454
Hyphenated Format 42858-454

Supplemental Identifiers

RxCUI
349287 351133
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

Packaging Origin

Original Packager
true

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 ANDA076433 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45)
source: ndc

Packages (1)

42858-454-45 90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45)

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": "2ee176e8-44de-4206-a71a-d0cbacdc0a81", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["5e7b79ab-9df0-4bbf-b7a4-a44aec203555"], "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": ["Rhodes Pharmaceuticals L.P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45)", "package_ndc": "42858-454-45", "marketing_start_date": "20170601"}], "brand_name": "Fenofibrate", "product_id": "42858-454_2ee176e8-44de-4206-a71a-d0cbacdc0a81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "42858-454", "generic_name": "Fenofibrate", "labeler_name": "Rhodes Pharmaceuticals L.P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA076433", "marketing_category": "ANDA", "marketing_start_date": "20170601", "listing_expiration_date": "20261231"}