Zetia (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

NDC 78206-178-01

Zetia® (ezetimibe) tablets

10 mg

Each tablet contains 10 mg ezetimibe.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Label
(click image for full-size original)
ZETIA ezetimibe tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:78206-178
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (CAPSULE-SHAPED) Size 8mm
Flavor Imprint Code 414
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78206-178-01 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021445 06/01/2021
Labeler — Organon LLC (117494753)

Revised: 06/2021 Organon LLC

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