FELODIPINEEXTENDED-RELEASE TABLETS
Approved
Approval ID
b951455c-c235-4e23-9e21-08672d108726
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2009
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc
DUNS: 937890044
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 Code63304-436
Application NumberNDA019834
Product Classification
M
Marketing Category
C73594
G
Generic Name
felodipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2009
FDA Product Classification
INGREDIENTS (5)
FELODIPINEActive
Quantity: 5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-437
Application NumberNDA019834
Product Classification
M
Marketing Category
C73594
G
Generic Name
felodipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2009
FDA Product Classification
INGREDIENTS (5)
FELODIPINEActive
Quantity: 10 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-435
Application NumberNDA019834
Product Classification
M
Marketing Category
C73594
G
Generic Name
felodipine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2009
FDA Product Classification
INGREDIENTS (7)
FELODIPINEActive
Quantity: 2.5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT