fenofibrate

Generic: fenofibrate

Labeler: bostal llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler bostal llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 67 mg/1

Manufacturer
Bostal LLC

Identifiers & Regulatory

Product NDC 35561-345
Product ID 35561-345_49fcfbe9-7313-d3e1-e063-6294a90a799f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207805
Listing Expiration 2027-12-31
Marketing Start 2017-11-17

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 35561345
Hyphenated Format 35561-345

Supplemental Identifiers

RxCUI
200311 310288 310289
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 ANDA207805 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 67 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (35561-345-11)
  • 100 CAPSULE in 1 BOTTLE (35561-345-12)
source: ndc

Packages (2)

35561-345-11 90 CAPSULE in 1 BOTTLE (35561-345-11) 35561-345-12 100 CAPSULE in 1 BOTTLE (35561-345-12)

Ingredients (1)

fenofibrate (67 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": "49fcfbe9-7313-d3e1-e063-6294a90a799f", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "unii": ["U202363UOS"], "rxcui": ["200311", "310288", "310289"], "spl_set_id": ["a5bc232c-ff27-f8b6-e053-2995a90ad399"], "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": ["Bostal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (35561-345-11)", "package_ndc": "35561-345-11", "marketing_start_date": "20171117"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (35561-345-12)", "package_ndc": "35561-345-12", "marketing_start_date": "20201120"}], "brand_name": "Fenofibrate", "product_id": "35561-345_49fcfbe9-7313-d3e1-e063-6294a90a799f", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "35561-345", "generic_name": "FENOFIBRATE", "labeler_name": "Bostal LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "67 mg/1"}], "application_number": "ANDA207805", "marketing_category": "ANDA", "marketing_start_date": "20171117", "listing_expiration_date": "20271231"}