Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lescol XL
Product Details
NDC Product Code
0078-0354Application Number
NDA021192Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
November 7, 2023FluvastatinActive
Code: PYF7O1FV7FClass: ACTIMQuantity: 80 mg in 1 1
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBNClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT