Lescol
These highlights do not include all the information needed to use Lescol XL safely and effectively. See full prescribing information for Lescol XL. Lescol XL (fluvastatin) extended-release tablets, for oral useInitial U.S. Approval: 1993
Approved
Approval ID
8a1823e7-26fb-4858-bac7-9e152e5ea16a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluvastatin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0354
Application NumberNDA021192
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluvastatin sodium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (10)
FLUVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT