fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-7816
Product ID 68788-7816_b46a4e6e-3b07-4dab-8676-6207928a92e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213864
Listing Expiration 2026-12-31
Marketing Start 2020-11-06

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 687887816
Hyphenated Format 68788-7816

Supplemental Identifiers

RxCUI
349287
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

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 ANDA213864 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-7816-3)
  • 60 TABLET in 1 BOTTLE (68788-7816-9)
source: ndc

Packages (2)

68788-7816-3 30 TABLET in 1 BOTTLE (68788-7816-3) 68788-7816-9 60 TABLET in 1 BOTTLE (68788-7816-9)

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": "b46a4e6e-3b07-4dab-8676-6207928a92e2", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["e573b3f1-5a4c-4a19-9f0f-ee797b379a08"], "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": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-7816-3)", "package_ndc": "68788-7816-3", "marketing_start_date": "20201106"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-7816-9)", "package_ndc": "68788-7816-9", "marketing_start_date": "20201106"}], "brand_name": "FENOFIBRATE", "product_id": "68788-7816_b46a4e6e-3b07-4dab-8676-6207928a92e2", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68788-7816", "generic_name": "FENOFIBRATE", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA213864", "marketing_category": "ANDA", "marketing_start_date": "20201106", "listing_expiration_date": "20261231"}