fenofibrate

Generic: fenofibrate

Labeler: chartwell rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler chartwell rx, llc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 67 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-893
Product ID 62135-893_459be037-d59a-9ee0-e063-6394a90a3b5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211407
Listing Expiration 2026-12-31
Marketing Start 2024-01-31

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 62135893
Hyphenated Format 62135-893

Supplemental Identifiers

RxCUI
200311 310288 310289
UPC
0362135899905 0362135894900 0362135893903
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 ANDA211407 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 67 mg/1
source: ndc
Packaging
  • 90 CAPSULE in 1 BOTTLE (62135-893-90)
source: ndc

Packages (1)

62135-893-90 90 CAPSULE in 1 BOTTLE (62135-893-90)

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": "459be037-d59a-9ee0-e063-6394a90a3b5e", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0362135899905", "0362135894900", "0362135893903"], "unii": ["U202363UOS"], "rxcui": ["200311", "310288", "310289"], "spl_set_id": ["2d0cfddc-ace3-4187-8d94-d760d23d20b6"], "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": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 CAPSULE in 1 BOTTLE (62135-893-90)", "package_ndc": "62135-893-90", "marketing_start_date": "20240912"}], "brand_name": "fenofibrate", "product_id": "62135-893_459be037-d59a-9ee0-e063-6394a90a3b5e", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "62135-893", "generic_name": "fenofibrate", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "67 mg/1"}], "application_number": "ANDA211407", "marketing_category": "ANDA", "marketing_start_date": "20240131", "listing_expiration_date": "20261231"}