fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler ani pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 134 mg/1

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43975-305
Product ID 43975-305_379ca6d7-14ee-4c36-a271-325d231a2fba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209504
Listing Expiration 2026-12-31
Marketing Start 2018-05-01

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 43975305
Hyphenated Format 43975-305

Supplemental Identifiers

RxCUI
200311 310288 310289
UPC
0343975305108 0343975444104 0343975306105
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 ANDA209504 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 134 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (43975-305-10)
  • 500 CAPSULE in 1 BOTTLE (43975-305-50)
source: ndc

Packages (2)

43975-305-10 100 CAPSULE in 1 BOTTLE (43975-305-10) 43975-305-50 500 CAPSULE in 1 BOTTLE (43975-305-50)

Ingredients (1)

fenofibrate (134 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": "379ca6d7-14ee-4c36-a271-325d231a2fba", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0343975305108", "0343975444104", "0343975306105"], "unii": ["U202363UOS"], "rxcui": ["200311", "310288", "310289"], "spl_set_id": ["c740f57c-cac5-4526-a5a9-aaab65b1caf6"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (43975-305-10)", "package_ndc": "43975-305-10", "marketing_start_date": "20180501"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (43975-305-50)", "package_ndc": "43975-305-50", "marketing_start_date": "20180501"}], "brand_name": "Fenofibrate", "product_id": "43975-305_379ca6d7-14ee-4c36-a271-325d231a2fba", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "43975-305", "generic_name": "Fenofibrate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "134 mg/1"}], "application_number": "ANDA209504", "marketing_category": "ANDA", "marketing_start_date": "20180501", "listing_expiration_date": "20261231"}