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
454af7e2-8734-4a56-b659-02e83d2024fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2021
Manufacturers
FDA
Athena Bioscience, LLC
DUNS: 080710928
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 Code71511-502
Application NumberNDA022418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2019
FDA Product Classification
INGREDIENTS (5)
Fenofibric AcidActive
Quantity: 105 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
crospovidoneInactive
Code: 2S7830E561
Classification: IACT
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Fenofibric Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71511-501
Application NumberNDA022418
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fenofibric Acid
Product Specifications
Route of AdministrationORAL
Effective DateMay 29, 2019
FDA Product Classification
INGREDIENTS (5)
Fenofibric AcidActive
Quantity: 35 mg in 1 1
Code: BGF9MN2HU1
Classification: ACTIB
Copovidone K25-31Inactive
Code: D9C330MD8B
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
crospovidoneInactive
Code: 2S7830E561
Classification: IACT