ypropyl cellulose, croscarmellose sodium, magnesium stearate, and lactose monohydrate; the tablets are film-coated with hypromellose, polyethylene glycol, titanium dioxide, talc and ferric oxide (yellow and/or red) and are marked with red A1 or gray F1 printing ink.
Distributed by Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. OSENI, NESINA and ACTOS are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and are used under license by Takeda Pharmaceuticals America, Inc.
©2013 – 2016 Takeda Pharmaceuticals America, Inc.
ALP008 R7
This Medication Guide has been approved by the U.S. Food and Drug Administration.
12/2016
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PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 12.5 mg/15 mg
NDC 64764-121-03
Oseni
(alogliptin and
pioglitazone) tablets
12.5 mg/15 mg
Rx Only
Dispense with
Medication Guide
Takeda logo
30 Tablets
12-5-15bottlelabel
CLOSE
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 12.5 mg/30 mg
NDC 64764-123-03
Oseni
(alogliptin and
pioglitazone) tablets
12.5 mg/30 mg
Rx Only
Dispense with
Medication Guide
Takeda logo
30 Tablets
12-5-30bottlelabel
CLOSE
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 12.5 mg/45 mg
NDC 64764-124-03
Oseni
(alogliptin and
pioglitazone) tablets
12.5 mg/45 mg
Rx Only
Dispense with
Medication Guide
Takeda logo
30 Tablets
12-5-45bottlelabel
CLOSE
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 25 mg/15 mg
NDC 64764-251-03
Oseni
(alogliptin and
pioglitazone) tablets
25 mg/15 mg
Rx Only
Dispense with
Medication Guide
Takeda logo
30 Tablets
25-15bottlelabel
CLOSE
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 25 mg/30 mg
NDC 64764-253-03
Oseni
(alogliptin and
pioglitazone) tablets
25 mg/30 mg
Rx Only
Dispense with
Medication Guide
Takeda logo
30 Tablets
25-30bottlelabel
CLOSE
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 25 mg/45 mg
NDC 64764-254-03
Oseni
(alogliptin and
pioglitazone) tablets
25 mg/45 mg
Rx Only
Dispense with
Medication Guide
Takeda logo
30 Tablets
25-45bottlelabel
CLOSE
INGREDIENTS AND APPEARANCE
OSENI
alogliptin and pioglitazone tablet, film coated
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64764-121
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 15 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: 15FIX