FIBRICOR
These highlights do not include all the information needed to use FIBRICOR (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
Approved
Approval ID
777b0c6b-cd25-454d-a35b-d2df9b44497f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2016
Manufacturers
FDA
Tribute Pharmaceuticals US, Inc.
DUNS: 079858728
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69916-105
Application NumberNDA022418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2016
FDA Product Classification
INGREDIENTS (5)
Fenofibric AcidActive
Quantity: 105 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69916-035
Application NumberNDA022418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2016
FDA Product Classification
INGREDIENTS (5)
Fenofibric AcidActive
Quantity: 35 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT