Marketing Information 
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022426 01/25/2013 
 
OSENI alogliptin and pioglitazone tablet, film coated 
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64764-253
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOGLIPTIN BENZOATE (ALOGLIPTIN)  ALOGLIPTIN 25 mg
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE)  PIOGLITAZONE 30 mg
 
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
HYDROXYPROPYL CELLULOSE (TYPE L)  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
HYPROMELLOSE 2910 (6 MPA.S)  
TITANIUM DIOXIDE  
POLYETHYLENE GLYCOL 8000  
TALC  
LACTOSE MONOHYDRATE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
SHELLAC  
CARNAUBA WAX  
POLYGLYCERYL-10 OLEATE  
BUTYL ALCOHOL  
ALCOHOL  
Product Characteristics
Color ORANGE (peach)  Score no score
Shape ROUND (biconvex)  Size 9mm
Flavor  Imprint Code AP;25;30
Contains 
Packaging
# Item Code Package Description Multilevel Packaging
1  NDC:64764-253-03 30 TABLET, FILM COATED in 1 BOTTLE None
2  NDC:64764-253-04 90 TABLET, FILM COATED in 1 BOTTLE None
3  NDC:64764-253-05 500 TABLET, FILM COATED in 1 BOTTLE None
4  NDC:64764-253-06 4 CARTON in 1 TRAY contains a CARTON
4   1 BLISTER PACK in 1 CARTON This package is contained within the TRAY (64764-253-06) and contains a BLISTER PACK
4   7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a CARTON and a TRAY (64764-253-06)

Marketing Information 
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022426 01/25/2013