Lescol XL (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NOVARTIS

NDC 0078-0354-15

Lescol® XL
(fluvastatin sodium)

Extended-Release Tablets

equivalent to
80 mg per tabletfluvastatin

30 tablets

Rx only

PRINCIPAL DISPLAY PANEL
								NOVARTIS
								NDC 0078-0354-15
								Lescol® XL fluvastatin sodium
								Extended-Release Tablets
								equivalent to 80 mg per tablet fluvastatin
								30 tablets
								Rx only
(click image for full-size original)
LESCOL XL fluvastatin sodium tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0354
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVASTATIN SODIUM (FLUVASTATIN) FLUVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL CELLULOSE
HYPROMELLOSE 2208 (15000 MPA.S)
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 8000
POTASSIUM BICARBONATE
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code Lescol;XL;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0354-05 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:0078-0354-15 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021192 10/06/2000
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 07/2021 Novartis Pharmaceuticals Corporation

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