fenofibrate

Generic: fenofibrate

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler torrent pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 67 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-440
Product ID 13668-440_6602b2c6-0128-4d70-8581-9abee72f152e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210782
Listing Expiration 2026-12-31
Marketing Start 2018-07-01

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 13668440
Hyphenated Format 13668-440

Supplemental Identifiers

RxCUI
200311 310288 310289
UPC
0313668438901 0313668439908 0313668440904
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 ANDA210782 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 67 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (13668-440-01)
  • 500 CAPSULE in 1 BOTTLE (13668-440-05)
  • 90 CAPSULE in 1 BOTTLE (13668-440-90)
source: ndc

Packages (3)

13668-440-01 100 CAPSULE in 1 BOTTLE (13668-440-01) 13668-440-05 500 CAPSULE in 1 BOTTLE (13668-440-05) 13668-440-90 90 CAPSULE in 1 BOTTLE (13668-440-90)

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": "6602b2c6-0128-4d70-8581-9abee72f152e", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0313668438901", "0313668439908", "0313668440904"], "unii": ["U202363UOS"], "rxcui": ["200311", "310288", "310289"], "spl_set_id": ["573ffb90-61a7-4b2d-b191-13de6c01d19e"], "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": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (13668-440-01)", "package_ndc": "13668-440-01", "marketing_start_date": "20180701"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (13668-440-05)", "package_ndc": "13668-440-05", "marketing_start_date": "20180701"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (13668-440-90)", "package_ndc": "13668-440-90", "marketing_start_date": "20180701"}], "brand_name": "Fenofibrate", "product_id": "13668-440_6602b2c6-0128-4d70-8581-9abee72f152e", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "13668-440", "generic_name": "Fenofibrate", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "67 mg/1"}], "application_number": "ANDA210782", "marketing_category": "ANDA", "marketing_start_date": "20180701", "listing_expiration_date": "20261231"}