Gemfibrozil
Gemfibrozil Tablets, USP Rx only
Approved
Approval ID
f20eb470-a6db-40c2-9113-8023eb0ea4d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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 Code53002-2068
Application NumberANDA202726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Gemfibrozil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2021
FDA Product Classification
INGREDIENTS (11)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
GEMFIBROZILActive
Quantity: 600 mg in 1 1
Code: Q8X02027X3
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT