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 54 mg/1

Manufacturer
Bostal LLC

Identifiers & Regulatory

Product NDC 35561-343
Product ID 35561-343_49fce536-9885-9845-e063-6394a90af375
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207803
Listing Expiration 2027-12-31
Marketing Start 2019-06-30

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 35561343
Hyphenated Format 35561-343

Supplemental Identifiers

RxCUI
349287 351133
UPC
0335561344134
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 ANDA207803 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 63784 TABLET, FILM COATED in 1 BOX (35561-343-00)
  • 90 TABLET, FILM COATED in 1 BOTTLE (35561-343-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE (35561-343-13)
source: ndc

Packages (3)

35561-343-00 63784 TABLET, FILM COATED in 1 BOX (35561-343-00) 35561-343-11 90 TABLET, FILM COATED in 1 BOTTLE (35561-343-11) 35561-343-13 500 TABLET, FILM COATED in 1 BOTTLE (35561-343-13)

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": "49fce536-9885-9845-e063-6394a90af375", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0335561344134"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["edace25a-3296-9ca7-dcb8-d0698f65840d"], "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": "63784 TABLET, FILM COATED in 1 BOX (35561-343-00)", "package_ndc": "35561-343-00", "marketing_start_date": "20190630"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (35561-343-11)", "package_ndc": "35561-343-11", "marketing_start_date": "20190630"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (35561-343-13)", "package_ndc": "35561-343-13", "marketing_start_date": "20190630"}], "brand_name": "Fenofibrate", "product_id": "35561-343_49fce536-9885-9845-e063-6394a90af375", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "35561-343", "generic_name": "Fenofibrate", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA207803", "marketing_category": "ANDA", "marketing_start_date": "20190630", "listing_expiration_date": "20271231"}