FDA.reportPublic FDA data

Lescol

Product NDC
0078-0354
11-digit product format
000780354
Labeler code
0078
Product ID
0078-0354_04f77269-0504-4ffb-88cf-5834cfc6b173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluvastatin sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0354-05EA - Each0078-03548016e7bf-ec59-4910-bd4b-55bc1dd7dbaa12012-07-24
0078-0354-15EA - Each0078-0354d7f38635-684e-4226-821b-ea904a2a7b8212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVASTATIN SODIUMACTIVE INGREDIENTPYF7O1FV7FLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
FLUVASTATINACTIVE MOIETY4L066368ASLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
GELATININACTIVE INGREDIENT2G86QN327LLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
POVIDONEINACTIVE INGREDIENTFZ989GH94ELESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
TALCINACTIVE INGREDIENT7SEV7J4R1ULESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLESCOL (FLUVASTATIN SODIUM) CAPSULE LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]10
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
FLUVASTATIN SODIUMACTIVE INGREDIENTPYF7O1FV7FLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FLUVASTATINACTIVE MOIETY4L066368ASLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSE 2208 (15000 MPA.S)INACTIVE INGREDIENTZ78RG6M2N2LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0354LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]24Legacy NDC20231209_8a1823e7-26fb-4858-bac7-9e152e5ea16a.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
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSN0d466214-78a8-44cd-923c-c286a0f74f661
687048Lescol XL 80 MG 24HR Extended Release Oral TabletPSN0d466214-78a8-44cd-923c-c286a0f74f661
68704824 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]SBD0d466214-78a8-44cd-923c-c286a0f74f661
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCD0d466214-78a8-44cd-923c-c286a0f74f661
68704824 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral TabletSY0d466214-78a8-44cd-923c-c286a0f74f661
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSY0d466214-78a8-44cd-923c-c286a0f74f661
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSY0d466214-78a8-44cd-923c-c286a0f74f661
687048Lescol XL 80 MG 24 HR Extended Release Oral TabletSY0d466214-78a8-44cd-923c-c286a0f74f661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0354-0500078035405100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-05) 2000-10-062021-02-28NoNoCurrent
0078-0354-150007803541530 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0354-15) 2000-10-060000-00-00NoNoCurrent