Fenoglide
These highlights do not include all the information needed to use FENOGLIDE safely and effectively. See full prescribing information for FENOGLIDE. FENOGLIDE® (fenofibrate) Tablets, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
35e89d4e-45cf-4374-bf93-fca8d40d783b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2021
Manufacturers
FDA
Santarus, Inc.
DUNS: 104286369
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68012-490
Application NumberNDA022118
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (5)
fenofibrateActive
Quantity: 40 mg in 1 1
Code: U202363UOS
Classification: ACTIB
Poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Polyethylene Glycol 6000Inactive
Code: 30IQX730WE
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
fenofibrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68012-495
Application NumberNDA022118
Product Classification
M
Marketing Category
C73594
G
Generic Name
fenofibrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (5)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
fenofibrateActive
Quantity: 120 mg in 1 1
Code: U202363UOS
Classification: ACTIB
Polyethylene Glycol 6000Inactive
Code: 30IQX730WE
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT