fenofibric acid

Generic: fenofibric acid

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibric acid
Generic Name fenofibric acid
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

fenofibric acid 45 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1324
Product ID 0115-1324_a1c48695-091f-4924-acf4-a420be16939d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200264
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

Established (EPC)
peroxisome proliferator receptor alpha agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151324
Hyphenated Format 0115-1324

Supplemental Identifiers

RxCUI
828373 828379
UPC
0301151325104
UNII
BGF9MN2HU1
NUI
N0000175596

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 fenofibric acid (source: ndc)
Generic Name fenofibric acid (source: ndc)
Application Number ANDA200264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1324-10)
source: ndc

Packages (1)

0115-1324-10 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1324-10)

Ingredients (1)

fenofibric acid (45 mg/1)

Linked Drug Pages (1)

Fenofibric Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a1c48695-091f-4924-acf4-a420be16939d", "openfda": {"nui": ["N0000175596"], "upc": ["0301151325104"], "unii": ["BGF9MN2HU1"], "rxcui": ["828373", "828379"], "spl_set_id": ["e73404c5-e0ee-48e9-8b09-7a00d7e18e6c"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1324-10)", "package_ndc": "0115-1324-10", "marketing_start_date": "20240601"}], "brand_name": "Fenofibric Acid", "product_id": "0115-1324_a1c48695-091f-4924-acf4-a420be16939d", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0115-1324", "generic_name": "FENOFIBRIC ACID", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibric Acid", "active_ingredients": [{"name": "FENOFIBRIC ACID", "strength": "45 mg/1"}], "application_number": "ANDA200264", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}