fenofibrate

Generic: fenofibrate

Labeler: ncs healthcare of ky, inc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler ncs healthcare of ky, inc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 160 mg/1

Manufacturer
NCS HealthCare of KY, Inc dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8270
Product ID 0615-8270_ba5a6f15-4de9-446b-9cb2-16b58a3d207d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210138
Listing Expiration 2026-12-31
Marketing Start 2018-07-20

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 06158270
Hyphenated Format 0615-8270

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 ANDA210138 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (0615-8270-39)
source: ndc

Packages (1)

0615-8270-39 30 TABLET in 1 BLISTER PACK (0615-8270-39)

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": "ba5a6f15-4de9-446b-9cb2-16b58a3d207d", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["fafbc0be-f0ba-4dcd-8aa5-89527bae5e84"], "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": ["NCS HealthCare of KY, Inc dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8270-39)", "package_ndc": "0615-8270-39", "marketing_start_date": "20190204"}], "brand_name": "fenofibrate", "product_id": "0615-8270_ba5a6f15-4de9-446b-9cb2-16b58a3d207d", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0615-8270", "generic_name": "fenofibrate", "labeler_name": "NCS HealthCare of KY, Inc dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA210138", "marketing_category": "ANDA", "marketing_start_date": "20180720", "listing_expiration_date": "20261231"}