fenofibrate

Generic: fenofibrate

Labeler: laurus labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler laurus labs limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 54 mg/1

Manufacturer
Laurus Labs Limited

Identifiers & Regulatory

Product NDC 42385-935
Product ID 42385-935_f0dfffd1-9c2c-0cbd-e053-2a95a90a908c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210606
Listing Expiration 2026-12-31
Marketing Start 2020-01-13

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 42385935
Hyphenated Format 42385-935

Supplemental Identifiers

RxCUI
349287 351133
UPC
0342385936902 0342385935905
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 ANDA210606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42385-935-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90)
source: ndc

Packages (4)

42385-935-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05) 42385-935-11 1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11) 42385-935-30 30 TABLET, FILM COATED in 1 BOTTLE (42385-935-30) 42385-935-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90)

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": "f0dfffd1-9c2c-0cbd-e053-2a95a90a908c", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0342385936902", "0342385935905"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["8e58c13a-8088-4fed-86cc-52530de5aa45"], "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": ["Laurus Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)", "package_ndc": "42385-935-05", "marketing_start_date": "20200113"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11)", "package_ndc": "42385-935-11", "marketing_start_date": "20200113"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42385-935-30)", "package_ndc": "42385-935-30", "marketing_start_date": "20200113"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (42385-935-90)", "package_ndc": "42385-935-90", "marketing_start_date": "20200113"}], "brand_name": "FENOFIBRATE", "product_id": "42385-935_f0dfffd1-9c2c-0cbd-e053-2a95a90a908c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "42385-935", "generic_name": "FENOFIBRATE", "labeler_name": "Laurus Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA210606", "marketing_category": "ANDA", "marketing_start_date": "20200113", "listing_expiration_date": "20261231"}