fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

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

fenofibrate 160 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4991
Product ID 68071-4991_1b3066de-04ac-9ff3-e063-6294a90a7adc
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 680714991
Hyphenated Format 68071-4991

Supplemental Identifiers

RxCUI
349287
UPC
0368071499193
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
  • 90 TABLET in 1 BOTTLE (68071-4991-9)
source: ndc

Packages (1)

68071-4991-9 90 TABLET in 1 BOTTLE (68071-4991-9)

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": "1b3066de-04ac-9ff3-e063-6294a90a7adc", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368071499193"], "unii": ["U202363UOS"], "rxcui": ["349287"], "spl_set_id": ["8e9898d1-1fc0-b7c6-e053-2a95a90a65cd"], "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": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-4991-9)", "package_ndc": "68071-4991-9", "marketing_start_date": "20190726"}], "brand_name": "fenofibrate", "product_id": "68071-4991_1b3066de-04ac-9ff3-e063-6294a90a7adc", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68071-4991", "generic_name": "fenofibrate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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"}