GEMFIBROZIL
Gemfibrozil Tablets, USP Rx Only
Approved
Approval ID
fd7c7a13-4d2a-4b98-8e1d-a1a99c3657e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code43063-921
Application NumberANDA078012
Product Classification
M
Marketing Category
C73584
G
Generic Name
GEMFIBROZIL
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GEMFIBROZILActive
Quantity: 600 mg in 1 1
Code: Q8X02027X3
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT