Felodipine
FELODIPINE EXTENDED-RELEASE TABLETS
Approved
Approval ID
4bfc1982-6fe6-4d6d-99f2-f2d1cd708540
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 17, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0826
Application NumberANDA075896
Product Classification
M
Marketing Category
C73584
G
Generic Name
felodipine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2010
FDA Product Classification
INGREDIENTS (14)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FELODIPINEActive
Quantity: 10 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0823
Application NumberANDA075896
Product Classification
M
Marketing Category
C73584
G
Generic Name
felodipine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2010
FDA Product Classification
INGREDIENTS (14)
FELODIPINEActive
Quantity: 2.5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
felodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5197
Application NumberANDA075896
Product Classification
M
Marketing Category
C73584
G
Generic Name
felodipine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2010
FDA Product Classification
INGREDIENTS (14)
FELODIPINEActive
Quantity: 5 mg in 1 1
Code: OL961R6O2C
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT