MedPath
FDA Product

Ezetimibe

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Ezetimibe

51660-200

Regulatory Information

51660-200

ANDA207311

C73584

March 5, 2024

USA

These highlights do not include all the information needed to use EZETIMIBE TABLETS safely and effectively. See full prescribing information for EZETIMIBE TABLETS. EZETIMIBE tablets, for oral use Initial U.S. Approval: 2002

HUMAN PRESCRIPTION DRUG LABEL

7

Company Information

184769029

Active Ingredients

EZETIMIBE

Quantity: 10 mg in 1 1

Code: EOR26LQQ24

Class Code: ACTIB

Inactive Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

Active Moieties

EZETIMIBE

Code: EOR26LQQ24

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