fenofibrate

Generic: fenofibrate

Labeler: alembic pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler alembic pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-539
Product ID 62332-539_ee0b43e8-d8dd-4a74-aac2-ee828d85b364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209660
Listing Expiration 2026-12-31
Marketing Start 2019-02-12

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 62332539
Hyphenated Format 62332-539

Supplemental Identifiers

RxCUI
349287 351133
UPC
0362332538904 0362332539901
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 ANDA209660 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (62332-539-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (62332-539-91)
source: ndc

Packages (2)

62332-539-90 90 TABLET, FILM COATED in 1 BOTTLE (62332-539-90) 62332-539-91 1000 TABLET, FILM COATED in 1 BOTTLE (62332-539-91)

Ingredients (1)

fenofibrate (160 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": "ee0b43e8-d8dd-4a74-aac2-ee828d85b364", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0362332538904", "0362332539901"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["4387adac-eea0-40c5-8111-1b70e0d98d7e"], "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": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62332-539-90)", "package_ndc": "62332-539-90", "marketing_start_date": "20190212"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (62332-539-91)", "package_ndc": "62332-539-91", "marketing_start_date": "20190212"}], "brand_name": "Fenofibrate", "product_id": "62332-539_ee0b43e8-d8dd-4a74-aac2-ee828d85b364", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "62332-539", "generic_name": "Fenofibrate", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA209660", "marketing_category": "ANDA", "marketing_start_date": "20190212", "listing_expiration_date": "20261231"}