9V2JP)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TALC (UNII: 7SEV7J4R1U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
ALCOHOL (UNII: 3K9958V90M)
SHELLAC (UNII: 46N107B71O)
PRODUCT CHARACTERISTICS
Color YELLOW (pale yellow) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code AP;12;5;15
Contains
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64764-121-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2013
2 NDC:64764-121-04 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2013
3 NDC:64764-121-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2013
4 NDC:64764-121-06 4 in 1 TRAY 01/25/2013
4 1 in 1 CARTON
4 7 in 1 BLISTER PACK; Type 0: Not a Combination Product
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:64764-123
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
ALOGLIPTIN BENZOATE (UNII: EEN99869SC) (ALOGLIPTIN - UNII:JHC049LO86) ALOGLIPTIN 12.5 mg
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S) PIOGLITAZONE 30 mg
INACTIVE INGREDIENTS
Ingredient Name Strength
MANNITOL (UNII: 3OWL53L36A)
HYDROXYPROPYL CELLULOSE (120000 MW) (UNII: UKE75GEA7F)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
TALC (UNII: 7SEV7J4R1U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
ALCOHOL (UNII: 3K9958V90M)
SHELLAC (UNII: 46N107B71O)
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 Marketing Start Date Marketing End Date
1 NDC:64764-123-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/25/2013
2 |
