Gemfibrozil
Rx Only
Approved
Approval ID
c3542eba-3c1d-57ba-e053-2995a90a517b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 27, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2422
Application NumberANDA079072
Product Classification
M
Marketing Category
C73584
G
Generic Name
gemfibrozil
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2021
FDA Product Classification
INGREDIENTS (11)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GEMFIBROZILActive
Quantity: 600 mg in 1 1
Code: Q8X02027X3
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT