s
Packaging
# Item Code Package Description
1 NDC:0006-0533-31 30 in 1 BOTTLE
2 NDC:0006-0533-54 90 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202343 09/18/2012
JUVISYNC
sitagliptin and simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-0535
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 50 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
LACTOSE MONOHYDRATE
STARCH, CORN
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
BUTYLATED HYDROXYANISOLE
Product Characteristics
Color ORANGE (ORANGE-BEIGE) Score no score
Shape OVAL (MODIFIED CAPSULE-SHAPED) Size 14mm
Flavor Imprint Code 535
Contains
Packaging
# Item Code Package Description
1 NDC:0006-0535-31 30 in 1 BOTTLE
2 NDC:0006-0535-54 90 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202343 09/18/2012
JUVISYNC
sitagliptin and simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-0537
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN) SITAGLIPTIN 50 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
SODIUM STEARYL FUMARATE
MAGNESIUM STEARATE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
LACTOSE MONOHYDRATE
STARCH, CORN
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
BUTYLATED HYDROXYANISOLE
Product Characteristics
Color RED Score no score
Shape OVAL (MODIFIED CAPSULE-SHAPED) Size 16mm
Flavor Imprint Code 537
Contains
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