fenofibrate

Generic: fenofibrate

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 134 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-581
Product ID 68462-581_6c9e4429-e3c7-4a34-ae48-d4e2a2bdf00f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205566
Listing Expiration 2027-12-31
Marketing Start 2017-04-07

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 68462581
Hyphenated Format 68462-581

Supplemental Identifiers

RxCUI
200311 310288 310289
UPC
0368462580011
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 ANDA205566 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 134 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (68462-581-01)
source: ndc

Packages (1)

68462-581-01 100 CAPSULE in 1 BOTTLE (68462-581-01)

Ingredients (1)

fenofibrate (134 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": "6c9e4429-e3c7-4a34-ae48-d4e2a2bdf00f", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0368462580011"], "unii": ["U202363UOS"], "rxcui": ["200311", "310288", "310289"], "spl_set_id": ["e7204052-02cf-4b38-835b-d8754c74b2cd"], "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": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (68462-581-01)", "package_ndc": "68462-581-01", "marketing_start_date": "20170407"}], "brand_name": "fenofibrate", "product_id": "68462-581_6c9e4429-e3c7-4a34-ae48-d4e2a2bdf00f", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "68462-581", "generic_name": "fenofibrate", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "134 mg/1"}], "application_number": "ANDA205566", "marketing_category": "ANDA", "marketing_start_date": "20170407", "listing_expiration_date": "20271231"}