NDC Code(s) : 0527-2580-32, 0527-2580-37
Packager : Lannett Company, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fluvastatin SodiumFluvastatin Sodium TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2580
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVASTATIN SODIUM(UNII: PYF7O1FV7F)
(FLUVASTATIN - UNII:4L066368AS) 		FLUVASTATIN80 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
POTASSIUM BICARBONATE(UNII: HM5Z15LEBN)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code BS08;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0527-2580-3230 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/07/2021
2NDC:0527-2580-37100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product14/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209397 05/07/2021

LABELER - Lannett Company, Inc.(002277481)

REGISTRANT - Lannett Company, Inc.(002277481)

Establishment
Name Address ID/FEI Business Operations
Beijing Sciecure Pharmaceutical Co., Ltd. 547707195 manufacture(0527-2580)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL – 80 mg

NDC 0527- 2580-32

Fluvastatin Sodium
Extended-Release
Tablets
80 mg*

30 Tablets

Rx only

*Each film-coated tablet contains fluvastatin
sodium, USP equivalent to 80 mg of fluvastatin.

Usual Dosage: See package insert.

Store at 25°C (77°F); excursions permitted to
15-30°C (59-86°F)
[see USP controlled room temperature].
Protect from light. Dispense in a tight container.
Keep this and all drugs out of the reach of children.

Mfd by:
Beijing Sciecure Pharmaceutical Co. Ltd.

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

Fluvastatin Label Sciecure 30 Tablets

NDC 0527- 2580-37

100 Tablets

Rx only

Fluvastatin Label Sciecure 30 Tablets