fenofibrate

Generic: fenofibrate

Labeler: bostal llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler bostal llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 145 mg/1

Manufacturer
Bostal LLC

Identifiers & Regulatory

Product NDC 35561-250
Product ID 35561-250_49fcad93-415f-0a28-e063-6294a90a8066
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208476
Listing Expiration 2027-12-31
Marketing Start 2021-01-01

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 35561250
Hyphenated Format 35561-250

Supplemental Identifiers

RxCUI
477560 477562
UPC
0335561249101 0335561250107 0335561249132 0335561250138
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 ANDA208476 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 145 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (35561-250-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE (35561-250-13)
source: ndc

Packages (2)

35561-250-10 30 TABLET, FILM COATED in 1 BOTTLE (35561-250-10) 35561-250-13 500 TABLET, FILM COATED in 1 BOTTLE (35561-250-13)

Ingredients (1)

fenofibrate (145 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": "49fcad93-415f-0a28-e063-6294a90a8066", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0335561249101", "0335561250107", "0335561249132", "0335561250138"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["7eb328d0-4e6f-4b24-ae85-68c2b3657569"], "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": ["Bostal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (35561-250-10)", "package_ndc": "35561-250-10", "marketing_start_date": "20210101"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (35561-250-13)", "package_ndc": "35561-250-13", "marketing_start_date": "20210101"}], "brand_name": "Fenofibrate", "product_id": "35561-250_49fcad93-415f-0a28-e063-6294a90a8066", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "35561-250", "generic_name": "Fenofibrate", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "145 mg/1"}], "application_number": "ANDA208476", "marketing_category": "ANDA", "marketing_start_date": "20210101", "listing_expiration_date": "20271231"}