Gemfibrozil
Gemfibrozil Tablets, USPRev. 12/10
Approved
Approval ID
b57eeb99-679e-4136-80f4-85421e21400b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 4, 2011
Manufacturers
FDA
Med-Health Pharma, LLC
DUNS: 962603812
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 Code51138-588
Application NumberANDA077836
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gemfibrozil
Product Specifications
Route of AdministrationORAL
Effective DateJuly 4, 2011
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GEMFIBROZILActive
Quantity: 600 mg in 1 1
Code: Q8X02027X3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
METHYLCELLULOSE (1500 MPA.S)Inactive
Code: P0NTE48364
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT