Gemfibrozil
GEMFIBROZIL TABLETS USP, 600 mg0670Rx only
Approved
Approval ID
7e877a90-e00f-45b2-a8e9-a9f70dfa8927
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 26, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2353
Application NumberANDA074256
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gemfibrozil
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2010
FDA Product Classification
INGREDIENTS (10)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GEMFIBROZILActive
Quantity: 600 mg in 1 1
Code: Q8X02027X3
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT