fenofibrate

Generic: fenofibrate

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

Drug Facts

Product Profile

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

fenofibrate 160 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-117
Product ID 27241-117_698b59bf-d672-4ea4-8f3d-dcaee5329a39
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210138
Listing Expiration 2027-12-31
Marketing Start 2018-07-20

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 27241117
Hyphenated Format 27241-117

Supplemental Identifiers

RxCUI
349287 351133
UPC
0327241117039 0327241116032
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 ANDA210138 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (27241-117-03)
  • 500 TABLET in 1 BOTTLE (27241-117-05)
source: ndc

Packages (2)

27241-117-03 90 TABLET in 1 BOTTLE (27241-117-03) 27241-117-05 500 TABLET in 1 BOTTLE (27241-117-05)

Ingredients (1)

fenofibrate (160 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": "698b59bf-d672-4ea4-8f3d-dcaee5329a39", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0327241117039", "0327241116032"], "unii": ["U202363UOS"], "rxcui": ["349287", "351133"], "spl_set_id": ["eb400ea7-bbd8-440b-b8be-082121621408"], "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": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (27241-117-03)", "package_ndc": "27241-117-03", "marketing_start_date": "20180720"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (27241-117-05)", "package_ndc": "27241-117-05", "marketing_start_date": "20180720"}], "brand_name": "fenofibrate", "product_id": "27241-117_698b59bf-d672-4ea4-8f3d-dcaee5329a39", "dosage_form": "TABLET", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "27241-117", "generic_name": "fenofibrate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "160 mg/1"}], "application_number": "ANDA210138", "marketing_category": "ANDA", "marketing_start_date": "20180720", "listing_expiration_date": "20271231"}