s
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 ROUND Size 10mm
Flavor Imprint Code 321
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66582-321-54 9 in 1 CARTON
1 NDC:66582-321-30 3 in 1 CARTON
1 NDC:66582-321-10 1 in 1 POUCH
1 1 in 1 CASE
1 10 in 1 BLISTER PACK
2 NDC:66582-321-27 4 in 1 CARTON
2 NDC:66582-321-11 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:66582-322
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 40 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 Size 14mm
Flavor Imprint Code 322
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66582-322-54 9 in 1 CARTON
1 NDC:66582-322-30 3 in 1 CARTON
1 NDC:66582-322-10 1 in 1 POUCH
1 1 in 1 CASE
1 10 in 1 BLISTER PACK
2 NDC:66582-322-27 4 in 1 CARTON
2 NDC:66582-322-11 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& |
