FELODIPINE
Felodipine Extended-Release Tablets, USP Rx only
Approved
Approval ID
b4d6ab4c-6bc9-42d4-acf2-9fb0e871fd8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2010
Manufacturers
FDA
WOCKHARDT LIMITED
DUNS: 650069115
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 Code55648-412
Application NumberANDA091484
Product Classification
M
Marketing Category
C73584
G
Generic Name
FELODIPINE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2010
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FELODIPINEActive
Quantity: 5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
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 Code55648-411
Application NumberANDA091484
Product Classification
M
Marketing Category
C73584
G
Generic Name
FELODIPINE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2010
FDA Product Classification
INGREDIENTS (10)
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FELODIPINEActive
Quantity: 2.5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FELODIPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55648-414
Application NumberANDA091484
Product Classification
M
Marketing Category
C73584
G
Generic Name
FELODIPINE
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2010
FDA Product Classification
INGREDIENTS (12)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FELODIPINEActive
Quantity: 10 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT