Rx only

30 Tablets

 
JUVISYNC 
sitagliptin and simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-0753
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN)  SITAGLIPTIN 100 mg
SIMVASTATIN (SIMVASTATIN)  SIMVASTATIN 10 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 PINK (PINK-BEIGE)  Score no score
Shape ROUND (ROUND)  Size 10mm
Flavor  Imprint Code 753 
Contains     
 
Packaging
# Item Code Package Description
1 NDC:0006-0753-31 30 in 1 BOTTLE
2 NDC:0006-0753-54 90 in 1 BOTTLE
3 NDC:0006-0753-82 1000 in 1 BOTTLE
 
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202343 10/07/2011 
 
JUVISYNC 
sitagliptin and simvastatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0006-0757
Route of Administration ORAL DEA Schedule      
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SITAGLIPTIN PHOSPHATE (SITAGLIPTIN)  SITAGLIPTIN 100 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 PINK (PINK-BEIGE)  Score no score
Shape OVAL (MODIFIED CAPSULE-SHAPED)  Size 16mm
Flavor  Imprint Code 757 
Contains     
 
Packaging
# Item Code Package Description
1 NDC:0006-0757-31 30 in 1 BOTTLE
2 NDC:0006-0757-54 90 in 1 BOTTLE