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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
PYF7O1FV7FFLUVASTATIN SODIUM93957-55-2FLUVASTATIN SODIUM

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
66758-211-316675802113130 TABLET, EXTENDED RELEASE in 1 BOTTLE (66758-211-31) 2024-08-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lescol XLSandoz Inc2023-12-13HUMAN PRESCRIPTION DRUG LABEL1