kage Insert.
Each tablet contains 10 mg of ezetimibe and 41.37 mg of
atorvastatin calcium, equivalent to 40 mg atorvastatin.
Rx only
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 10 mg/80 mg Tablet Carton
This carton
contains
3 patient pouches.
Each pouch
contains 10 tablets.
NDC 66582-323-30
Liptruzet™
(ezetimibe and atorvastatin) tablets
10 mg/80 mg
Do not open pouch until you are ready to use LIPTRUZET.
After the foil pouch is opened, protect LIPTRUZET from
moisture and light. Once a tablet is removed, slide
blister card back into case. Store case in a dry place
and discard any unused tablets 30 days after the
pouch is opened.
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C
(59-86°F) [see USP Controlled Room Temperature].
USUAL ADULT DOSAGE: See Package Insert.
Each tablet contains 10 mg of ezetimibe and 82.73 mg of
atorvastatin calcium, equivalent to 80 mg atorvastatin.
Rx only
INGREDIENTS AND APPEARANCE
LIPTRUZET
ezetimibe and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66582-320
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24) EZETIMIBE 10 mg
ATORVASTATIN CALCIUM (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POVIDONE K29/32 (UNII: 390RMW2PEQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (capsule-shaped) Size 17mm
Flavor Imprint Code 320
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66582-320-54 9 in 1 CARTON
1 NDC:66582-320-30 3 in 1 CARTON
1 NDC:66582-320-10 1 in 1 POUCH
1 1 in 1 CASE
1 10 in 1 BLISTER PACK
2 NDC:66582-320-27 4 in 1 CARTON
2 NDC:66582-320-11 1 in 1 POUCH
2 7 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200153 05/03/2013
LIPTRUZET
ezetimibe and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66582-321
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24) EZETIMIBE 10 mg
ATORVASTATIN CALCIUM (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN 20 mg
Inactive Ingredient |
