Felodipine
Felodipine Extended-Release Tablets USP
Approved
Approval ID
2e4298cf-02e9-49c7-9803-887161e1989a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2018
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-233
Application NumberANDA090365
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
FDA Product Classification
INGREDIENTS (13)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FELODIPINEActive
Quantity: 2.5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-234
Application NumberANDA090365
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FELODIPINEActive
Quantity: 5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
Felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68462-235
Application NumberANDA090365
Product Classification
M
Marketing Category
C73584
G
Generic Name
Felodipine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2018
FDA Product Classification
INGREDIENTS (12)
FELODIPINEActive
Quantity: 10 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT