fenofibrate

Generic: fenofibrate

Labeler: solco healthcare us, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler solco healthcare us, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 48 mg/1

Manufacturer
Solco Healthcare US, LLC

Identifiers & Regulatory

Product NDC 43547-430
Product ID 43547-430_df788edb-0354-46af-ae1f-f718f752f31b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211080
Listing Expiration 2026-12-31
Marketing Start 2019-02-20

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 43547430
Hyphenated Format 43547-430

Supplemental Identifiers

RxCUI
477560 477562
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 ANDA211080 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (43547-430-09)
  • 500 TABLET in 1 BOTTLE (43547-430-50)
source: ndc

Packages (2)

43547-430-09 90 TABLET in 1 BOTTLE (43547-430-09) 43547-430-50 500 TABLET in 1 BOTTLE (43547-430-50)

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": "df788edb-0354-46af-ae1f-f718f752f31b", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["085109a6-f006-44f0-a170-980d8899a365"], "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": ["Solco Healthcare US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-430-09)", "package_ndc": "43547-430-09", "marketing_start_date": "20190220"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-430-50)", "package_ndc": "43547-430-50", "marketing_start_date": "20190220"}], "brand_name": "FENOFIBRATE", "product_id": "43547-430_df788edb-0354-46af-ae1f-f718f752f31b", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "43547-430", "generic_name": "fenofibrate", "labeler_name": "Solco Healthcare US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "48 mg/1"}], "application_number": "ANDA211080", "marketing_category": "ANDA", "marketing_start_date": "20190220", "listing_expiration_date": "20261231"}