fenofibric acid

Generic: fenofibric acid

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC 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 0115-1554
Product ID 0115-1554_72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022224
Marketing Start 2016-09-12
Marketing End 2026-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151554
Hyphenated Format 0115-1554

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 NDA022224 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1554-10)
source: ndc

Packages (1)

0115-1554-10 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1554-10)

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": "72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a", "openfda": {"nui": ["N0000175596"], "unii": ["BGF9MN2HU1"], "rxcui": ["828373", "828379"], "spl_set_id": ["369b3e55-2c05-d879-fe7e-91296c529ae9"], "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 (0115-1554-10)", "package_ndc": "0115-1554-10", "marketing_end_date": "20260731", "marketing_start_date": "20160912"}], "brand_name": "Fenofibric Acid", "product_id": "0115-1554_72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "0115-1554", "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": "NDA022224", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260731", "marketing_start_date": "20160912"}