NDC 52725-495

Fenoglide

Fenofibrate

Fenoglide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Shore Therapeutics, Inc. The primary component is Fenofibrate.

• Product ID: 52725-495_986c60c0-7d75-11e0-b654-0002a5d5c51b
• NDC: 52725-495
• Product Type: Human Prescription Drug
• Proprietary Name: Fenoglide
• Generic Name: Fenofibrate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-11-18
• Marketing Category: NDA / NDA
• Application Number: NDA022118
• Labeler Name: Shore Therapeutics, Inc
• Substance Name: FENOFIBRATE
• Active Ingredient Strength: 120 mg/1
• Pharm Classes: Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 52725-495-07

6 BOTTLE, PLASTIC in 1 BOX (52725-495-07) > 7 TABLET in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2010-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52725-495-07 [52725049507]

Fenoglide TABLET

• Marketing Category: NDA
• Application Number: NDA022118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-05-17
• Inactivation Date: 2020-01-31

NDC 52725-495-90 [52725049590]

Fenoglide TABLET

• Marketing Category: NDA
• Application Number: NDA022118
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-11-18
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
FENOFIBRATE	120 mg/1

OpenFDA Data

• SPL SET ID: b38489c0-ee7b-11df-b958-0002a5d5c51b
• Manufacturer:
  • Shore Therapeutics, Inc
• UNII:
  • U202363UOS
• RxNorm Concept Unique ID - RxCUI:
  • 749802
  • 749804
  • 763250
  • 763252
• UPC Code:
  • 0352725490902

Pharmacological Class

• Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]
• PPAR alpha [CS]
• Peroxisome Proliferator Receptor alpha Agonist [EPC]

NDC Crossover Matching brand name "Fenoglide" or generic name "Fenofibrate"

NDC	Brand Name	Generic Name
68012-490	Fenoglide	Fenoglide
68012-495	Fenoglide	Fenoglide
52725-490	Fenoglide	Fenoglide
52725-495	Fenoglide	Fenoglide
0093-7755	Fenofibrate	Fenofibrate
0093-7756	Fenofibrate	Fenofibrate
0115-0511	Fenofibrate	FENOFIBRATE
0115-0522	Fenofibrate	FENOFIBRATE
0115-0533	Fenofibrate	FENOFIBRATE
0115-1522	Fenofibrate	Fenofibrate
0115-1523	Fenofibrate	Fenofibrate
0115-5511	FENOFIBRATE	FENOFIBRATE
0115-5522	FENOFIBRATE	FENOFIBRATE
0074-3173	Tricor	Fenofibrate
0074-3189	Tricor	Fenofibrate