Gemfibrozil
Gemfibrozil Tablets, USP 600 mg
Approved
Approval ID
1b1fa50e-6bb3-40d9-addc-48c37b8e1c49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Gemfibrozil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-146
Application NumberANDA075034
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gemfibrozil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2014
FDA Product Classification
INGREDIENTS (9)
GEMFIBROZILActive
Quantity: 600 mg in 1 1
Code: Q8X02027X3
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT