fenofibrate

Generic: fenofibrate

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

fenofibrate 48 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-459
Product ID 69097-459_ee5bc824-e200-4a5f-9374-bf71e665aeaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208709
Listing Expiration 2026-12-31
Marketing Start 2016-12-15

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 69097459
Hyphenated Format 69097-459

Supplemental Identifiers

RxCUI
477560 477562
UPC
0369097458058
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 ANDA208709 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 48 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-459-02)
  • 90 TABLET in 1 BOTTLE (69097-459-05)
source: ndc

Packages (2)

69097-459-02 30 TABLET in 1 BOTTLE (69097-459-02) 69097-459-05 90 TABLET in 1 BOTTLE (69097-459-05)

Ingredients (1)

fenofibrate (48 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": "ee5bc824-e200-4a5f-9374-bf71e665aeaa", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0369097458058"], "unii": ["U202363UOS"], "rxcui": ["477560", "477562"], "spl_set_id": ["f8f09ab1-74db-4123-b85a-6337dc2582a0"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-459-02)", "package_ndc": "69097-459-02", "marketing_start_date": "20161215"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (69097-459-05)", "package_ndc": "69097-459-05", "marketing_start_date": "20161215"}], "brand_name": "Fenofibrate", "product_id": "69097-459_ee5bc824-e200-4a5f-9374-bf71e665aeaa", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "69097-459", "generic_name": "FENOFIBRATE", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "48 mg/1"}], "application_number": "ANDA208709", "marketing_category": "ANDA", "marketing_start_date": "20161215", "listing_expiration_date": "20261231"}