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LIPTRUZET
ezetimibe and atorvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66582-323
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 80 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 19mm
Flavor Imprint Code 323
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66582-323-54 9 in 1 CARTON
1 NDC:66582-323-30 3 in 1 CARTON
1 NDC:66582-323-10 1 in 1 POUCH
1 1 in 1 CASE
1 10 in 1 BLISTER PACK
2 NDC:66582-323-27 4 in 1 CARTON
2 NDC:66582-323-11 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
Labeler - Merck Sharp & Dohme Corp. (110456618)
Establishment
Name Address ID/FEI Business Operations
MSD International GmbH (Singapore Branch) 894726637 MANUFACTURE(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
MSD International GmbH (Puerto Rico Branch) LLC 967475950 MANUFACTURE(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
Patheon Pharmaceuticals Inc. 005286822 MANUFACTURE(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
MSD International GmbH (Puerto Rico Branch) LLC 606266625 MANUFACTURE(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
DR. REDDY'S LABORATORIES LIMITED 650443679 API MANUFACTURE(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
MSD International GmbH (Singapore Branch) 595320830 API MANUFACTURE(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
AndersonBrecon Inc. 053217022 PACK(66582-320, 66582-321, 66582-322, 66582-323)
Establishment
Name Address ID/FEI Business Operations
Merck Sharp & Dohme Corp. 101740835 PACK(66582-320, 66582-321, 66582-322, 66582-323)) |
