fenofibrate

Generic: fenofibrate

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fenofibrate
Generic Name fenofibrate
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fenofibrate 130 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-310
Product ID 72789-310_4bbc4809-ec1c-375d-e063-6394a90a1cfc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201748
Listing Expiration 2027-12-31
Marketing Start 2015-03-02

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 72789310
Hyphenated Format 72789-310

Supplemental Identifiers

RxCUI
483425
UPC
0372789310305
UNII
U202363UOS
NUI
N0000175596 N0000175375 M0543661

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 ANDA201748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 130 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30)
source: ndc

Packages (1)

72789-310-30 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30)

Ingredients (1)

fenofibrate (130 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": "4bbc4809-ec1c-375d-e063-6394a90a1cfc", "openfda": {"nui": ["N0000175596", "N0000175375", "M0543661"], "upc": ["0372789310305"], "unii": ["U202363UOS"], "rxcui": ["483425"], "spl_set_id": ["2f5cee5c-ec55-4e9b-9d54-e7f2f052130e"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30)", "package_ndc": "72789-310-30", "marketing_start_date": "20220315"}], "brand_name": "Fenofibrate", "product_id": "72789-310_4bbc4809-ec1c-375d-e063-6394a90a1cfc", "dosage_form": "CAPSULE", "pharm_class": ["Peroxisome Proliferator Receptor alpha Agonist [EPC]"], "product_ndc": "72789-310", "generic_name": "Fenofibrate", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fenofibrate", "active_ingredients": [{"name": "FENOFIBRATE", "strength": "130 mg/1"}], "application_number": "ANDA201748", "marketing_category": "ANDA", "marketing_start_date": "20150302", "listing_expiration_date": "20271231"}