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, COATED
Routes
ORAL
Active Ingredients

fenofibrate 48 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2369
Product ID 68071-2369_4b45622d-5001-33a3-e063-6394a90afb6e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205118
Listing Expiration 2027-12-31
Marketing Start 2016-05-05

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 680712369
Hyphenated Format 68071-2369

Supplemental Identifiers

RxCUI
477562
UPC
0368071236996
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 ANDA205118 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 mg/1
source: ndc
Packaging
  • 90 TABLET, COATED in 1 BOTTLE (68071-2369-9)
source: ndc

Packages (1)

68071-2369-9 90 TABLET, COATED in 1 BOTTLE (68071-2369-9)

Ingredients (1)

fenofibrate (48 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": "4b45622d-5001-33a3-e063-6394a90afb6e", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368071236996"], "unii": ["U202363UOS"], "rxcui": ["477562"], "spl_set_id": ["bdc2211e-6d65-1500-e053-2a95a90ab145"], "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, COATED in 1 BOTTLE (68071-2369-9)", "package_ndc": "68071-2369-9", "marketing_start_date": "20210317"}], "brand_name": "Fenofibrate", "product_id": "68071-2369_4b45622d-5001-33a3-e063-6394a90afb6e", "dosage_form": "TABLET, COATED", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68071-2369", "generic_name": "Fenofibrate", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "48 mg/1"}], "application_number": "ANDA205118", "marketing_category": "ANDA", "marketing_start_date": "20160505", "listing_expiration_date": "20271231"}