AL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOGLIPTIN BENZOATE (ALOGLIPTIN) ALOGLIPTIN 12.5 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 YELLOW
FERRIC OXIDE RED
SHELLAC
CARNAUBA WAX
POLYGLYCERYL-10 OLEATE
BUTYL ALCOHOL
ALCOHOL
Product Characteristics
Color ORANGE (pale peach) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;12;5;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64764-123-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64764-123-04 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64764-123-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:64764-123-06 4 CARTON in 1 TRAY contains a CARTON
4 1 BLISTER PACK in 1 CARTON This package is contained within the TRAY (64764-123-06) and contains a BLISTER PACK
4 7 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within a CARTON and a TRAY (64764-123-06)
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:64764-124
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALOGLIPTIN BENZOATE (ALOGLIPTIN) ALOGLIPTIN 12.5 mg
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE) PIOGLITAZONE 45 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
SHELLAC
CARNAUBA WAX
POLYGLYCERYL-10 OLEATE
BUTYL ALCOHOL
ALCOHOL
Product Characteristics
Color RED (pale red) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;12;5;45
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64764-124-03 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:64764-124-04 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:64764-124-05 500 TABLET, FILM COATED in 1 BOTTLE No |
