FDA.reportPublic FDA data

Lescol

Product NDC
68151-4471
11-digit product format
681514471
Labeler code
68151
Product ID
68151-4471_28e0a855-0be8-480d-9aaf-bdf8be6d2df1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluvastatin sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021192
Marketing category
NDA
Marketing start
2000-10-06
Marketing end
0000-00-00
Substance
FLUVASTATIN SODIUM
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
22ca7ed4-2e69-d74c-9eff-803d6d02a7beProduct name420211021

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4471-12020-01-31C16284748780-19d75b9cf-f03e-f424-e053-dadaa90a57ceThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4471-1Lescol XL1 in 1 PACKAGETABLET, EXTENDED RELEASE12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVASTATIN SODIUMACTIVE INGREDIENTPYF7O1FV7FLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FLUVASTATINACTIVE MOIETY4L066368ASLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ELESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4471LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140822_cd12fae6-f277-4679-a7a8-b98719fe6fa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSNcd12fae6-f277-4679-a7a8-b98719fe6fa92
687048Lescol XL 80 MG 24HR Extended Release Oral TabletPSNcd12fae6-f277-4679-a7a8-b98719fe6fa92
68704824 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]SBDcd12fae6-f277-4679-a7a8-b98719fe6fa92
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCDcd12fae6-f277-4679-a7a8-b98719fe6fa92
68704824 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral TabletSYcd12fae6-f277-4679-a7a8-b98719fe6fa92
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSYcd12fae6-f277-4679-a7a8-b98719fe6fa92
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSYcd12fae6-f277-4679-a7a8-b98719fe6fa92
687048Lescol XL 80 MG 24 HR Extended Release Oral TabletSYcd12fae6-f277-4679-a7a8-b98719fe6fa92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4471-1681514471011 in 1 PACKAGEHistorical