fenofibric acid

Generic: fenofibric acid

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

Drug Facts

Product Profile

Brand Name fenofibric acid
Generic Name fenofibric acid
Labeler leading pharma, llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

fenofibric acid 135 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-282
Product ID 69315-282_17afd47a-c2eb-411b-8b6c-6c1ce709dbbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211626
Listing Expiration 2026-12-31
Marketing Start 2019-07-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315282
Hyphenated Format 69315-282

Supplemental Identifiers

RxCUI
828373 828379
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 ANDA211626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 135 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69315-282-09)
source: ndc

Packages (1)

69315-282-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69315-282-09)

Ingredients (1)

fenofibric acid (135 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": "17afd47a-c2eb-411b-8b6c-6c1ce709dbbf", "openfda": {"nui": ["N0000175596"], "unii": ["BGF9MN2HU1"], "rxcui": ["828373", "828379"], "spl_set_id": ["daa488be-f580-430c-a72c-80ac31bb3e40"], "pharm_class_epc": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69315-282-09)", "package_ndc": "69315-282-09", "marketing_start_date": "20190718"}], "brand_name": "FENOFIBRIC ACID", "product_id": "69315-282_17afd47a-c2eb-411b-8b6c-6c1ce709dbbf", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "69315-282", "generic_name": "FENOFIBRIC ACID", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FENOFIBRIC ACID", "active_ingredients": [{"name": "FENOFIBRIC ACID", "strength": "135 mg/1"}], "application_number": "ANDA211626", "marketing_category": "ANDA", "marketing_start_date": "20190718", "listing_expiration_date": "20261231"}