fenofibrate

Generic: fenofibrate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler sun pharmaceutical industries, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 130 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-444
Product ID 63304-444_f26726b3-a91e-45bc-a02e-a560d898362a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201748
Listing Expiration 2026-12-31
Marketing Start 2015-03-02

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 63304444
Hyphenated Format 63304-444

Supplemental Identifiers

RxCUI
483425 483427
UPC
0363304443301 0363304444902
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 ANDA201748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 130 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (63304-444-05)
  • 30 CAPSULE in 1 BOTTLE (63304-444-30)
  • 90 CAPSULE in 1 BOTTLE (63304-444-90)
source: ndc

Packages (3)

63304-444-05 500 CAPSULE in 1 BOTTLE (63304-444-05) 63304-444-30 30 CAPSULE in 1 BOTTLE (63304-444-30) 63304-444-90 90 CAPSULE in 1 BOTTLE (63304-444-90)

Ingredients (1)

fenofibrate (130 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": "f26726b3-a91e-45bc-a02e-a560d898362a", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0363304443301", "0363304444902"], "unii": ["U202363UOS"], "rxcui": ["483425", "483427"], "spl_set_id": ["2083f5d9-92f2-4c64-b996-fabbd6946ea0"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (63304-444-05)", "package_ndc": "63304-444-05", "marketing_start_date": "20150302"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (63304-444-30)", "package_ndc": "63304-444-30", "marketing_start_date": "20150302"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (63304-444-90)", "package_ndc": "63304-444-90", "marketing_start_date": "20150302"}], "brand_name": "Fenofibrate", "product_id": "63304-444_f26726b3-a91e-45bc-a02e-a560d898362a", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "63304-444", "generic_name": "Fenofibrate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "130 mg/1"}], "application_number": "ANDA201748", "marketing_category": "ANDA", "marketing_start_date": "20150302", "listing_expiration_date": "20261231"}