Lescol
These highlights do not include all the information needed to use Lescol / Lescol XL safely and effectively. See full prescribing information for Lescol / Lescol XL. Lescol (fluvastatin sodium) capsules/ Lescol XL (fluvastatin sodium) extended-release tablets for oral use Initial U.S. Approval: 1993/ 2000
Approved
Approval ID
cd12fae6-f277-4679-a7a8-b98719fe6fa9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2012
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-4471
Application NumberNDA021192
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluvastatin sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2012
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FLUVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT