Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Felodipine
Product Details
NDC Product Code
54868-0826Application Number
ANDA075896Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2010CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FelodipineActive
Code: OL961R6O2CClass: ACTIBQuantity: 10 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Felodipine
Product Details
NDC Product Code
54868-0823Application Number
ANDA075896Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2010FelodipineActive
Code: OL961R6O2CClass: ACTIBQuantity: 2.5 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Felodipine
Product Details
NDC Product Code
54868-5197Application Number
ANDA075896Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 31, 2010FelodipineActive
Code: OL961R6O2CClass: ACTIBQuantity: 5 mg in 1 1
CARNAUBA WAXInactive
Code: R12CBM0EIZClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WOClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT