fenofibrate

Generic: fenofibrate

Labeler: lifestar pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler lifestar pharma llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 54 mg/1

Manufacturer
Lifestar Pharma LLC

Identifiers & Regulatory

Product NDC 70756-214
Product ID 70756-214_4a13e20b-6a21-4d45-a159-a2add4ce215e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213864
Listing Expiration 2026-12-31
Marketing Start 2020-09-10

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 70756214
Hyphenated Format 70756-214

Supplemental Identifiers

RxCUI
349287 351133
UPC
0370756215516
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 ANDA213864 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 54 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (70756-214-51)
  • 90 TABLET in 1 BOTTLE (70756-214-90)
source: ndc

Packages (2)

70756-214-51 500 TABLET in 1 BOTTLE (70756-214-51) 70756-214-90 90 TABLET in 1 BOTTLE (70756-214-90)

Ingredients (1)

fenofibrate (54 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": "4a13e20b-6a21-4d45-a159-a2add4ce215e", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0370756215516"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["1da57e8c-3977-43e1-aa7e-229760203f7d"], "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": ["Lifestar Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (70756-214-51)", "package_ndc": "70756-214-51", "marketing_start_date": "20200910"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70756-214-90)", "package_ndc": "70756-214-90", "marketing_start_date": "20200910"}], "brand_name": "FENOFIBRATE", "product_id": "70756-214_4a13e20b-6a21-4d45-a159-a2add4ce215e", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "70756-214", "generic_name": "FENOFIBRATE", "labeler_name": "Lifestar Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRATE", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "54 mg/1"}], "application_number": "ANDA213864", "marketing_category": "ANDA", "marketing_start_date": "20200910", "listing_expiration_date": "20261231"}