FDA.reportPublic FDA data

Lescol

Product NDC
66758-211
11-digit product format
667580211
Labeler code
66758
Product ID
66758-211_726ea2db-f1b0-4b73-a515-02157db88a42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluvastatin sodium
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA021192
Marketing category
NDA
Marketing start
2000-10-06
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lescol
Brand name suffix
XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVASTATIN SODIUM80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPYF7O1FV7F
Rxcui360507, 687048

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-211-01LescolXL100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
66758-211-31LescolXL30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-211-31EA - Each66758-211b86e6f02-b04f-4539-b688-76ff9d48573e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-211LESCOL XL (FLUVASTATIN SODIUM) TABLET, EXTENDED RELEASE [SANDOZ INC]1Current NDC, 2 package rows20240805_726ea2db-f1b0-4b73-a515-02157db88a42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360507fluvastatin sodium 80 MG 24HR Extended Release Oral TabletPSN726ea2db-f1b0-4b73-a515-02157db88a421
687048Lescol XL 80 MG 24HR Extended Release Oral TabletPSN726ea2db-f1b0-4b73-a515-02157db88a421
68704824 HR fluvastatin 80 MG Extended Release Oral Tablet [Lescol]SBD726ea2db-f1b0-4b73-a515-02157db88a421
36050724 HR fluvastatin 80 MG Extended Release Oral TabletSCD726ea2db-f1b0-4b73-a515-02157db88a421
68704824 HR Lescol XL (as fluvastatin sodium) 80 MG Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421
360507fluvastatin (as fluvastatin sodium) 80 MG 24 HR Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421
360507fluvastatin 80 MG 24 HR Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421
687048Lescol XL 80 MG 24 HR Extended Release Oral TabletSY726ea2db-f1b0-4b73-a515-02157db88a421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66758-211-0166758021101100 in 1 BOTTLEHistorical
66758-211-316675802113130 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31) 2024-08-02NoNoCurrent