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
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LESCOL
Product Details
NDC Product Code
54868-3329Application Number
NDA020261Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 23, 2011METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
FluvastatinActive
Code: PYF7O1FV7FClass: ACTIBQuantity: 20 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGKClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
LESCOL
Product Details
NDC Product Code
54868-4224Application Number
NDA020261Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 23, 2011BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
FluvastatinActive
Code: PYF7O1FV7FClass: ACTIBQuantity: 40 mg in 1 1
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QOClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGKClass: IACT