FDA.reportPublic FDA data

OSENI

Product NDC
64764-254
11-digit product format
647640254
Labeler code
64764
Product ID
64764-254_2346b7f5-b2c1-45f0-9f8f-5cbb4b202857
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alogliptin and pioglitazone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA022426
Marketing category
NDA
Marketing start
2013-01-25
Substance
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active strength
25; 45 mg/1; mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OSENI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOGLIPTIN BENZOATE25 mg/1
PIOGLITAZONE HYDROCHLORIDE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C, EEN99869SC
Rxcui1368410, 1368416, 1368424, 1368430, 1368431, 1368437, 1368438, 1368444

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
36db81cb-9c11-39e1-6a1a-715fc2caa47cProduct name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-254-03OSENI30 in 1 BOTTLETABLET, FILM COATED3023
64764-254-04OSENI90 in 1 BOTTLETABLET, FILM COATED9023
64764-254-05OSENI500 in 1 BOTTLETABLET, FILM COATED50023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-254-03EA - Each64764-254ccdc0409-5cee-49e5-8466-1464f4cc467012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALOGLIPTIN BENZOATEACTIVE INGREDIENTEEN99869SCOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6COSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
ALOGLIPTINACTIVE MOIETYJHC049LO86OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
PIOGLITAZONEACTIVE MOIETYX4OV71U42SOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
POLYGLYCERYL-10 OLEATEINACTIVE INGREDIENT55C81W76DHOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-254OSENI (ALOGLIPTIN AND PIOGLITAZONE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]23Current NDC, Legacy NDC, 3 package rows20250322_4c619ed9-fe3e-4158-9938-80c6c3493d55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368410alogliptin 12.5 MG / pioglitazone 30 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368424alogliptin 25 MG / pioglitazone 15 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368431alogliptin 25 MG / pioglitazone 30 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368438alogliptin 25 MG / pioglitazone 45 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368416Oseni 12.5 MG / 30 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368430Oseni 25 MG / 15 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368437Oseni 25 MG / 30 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368444Oseni 25 MG / 45 MG Oral TabletPSN4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368416alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet [Oseni]SBD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368430alogliptin 25 MG / pioglitazone 15 MG Oral Tablet [Oseni]SBD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368437alogliptin 25 MG / pioglitazone 30 MG Oral Tablet [Oseni]SBD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368444alogliptin 25 MG / pioglitazone 45 MG Oral Tablet [Oseni]SBD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368410alogliptin 12.5 MG / pioglitazone 30 MG Oral TabletSCD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368424alogliptin 25 MG / pioglitazone 15 MG Oral TabletSCD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368431alogliptin 25 MG / pioglitazone 30 MG Oral TabletSCD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368438alogliptin 25 MG / pioglitazone 45 MG Oral TabletSCD4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368410alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368424alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 15 MG (as pioglitazone hydrochloride 16.53 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368431alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368438alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 45 MG (as pioglitazone hydrochloride 49.59 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368416Oseni 12.5/30 (as alogliptin benzoate 17 MG / pioglitazone hydrochloride 33.06 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368416Oseni 12.5/30 Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368430Oseni 25/15 (as alogliptin benzoate 34 MG / pioglitazone hydrochloride 16.53 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368430Oseni 25/15 Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368437Oseni 25/30 (as alogliptin benzoate 34 MG / pioglitazone hydrochloride 33.06 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368437Oseni 25/30 Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368444Oseni 25/45 (as alogliptin benzoate 34 MG / pioglitazone hydrochloride 49.59 MG) Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523
1368444Oseni 25/45 Oral TabletSY4c619ed9-fe3e-4158-9938-80c6c3493d5523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64764-254-036476402540330 TABLET, FILM COATED in 1 BOTTLE (64764-254-03) 2013-01-250000-00-00NoNoCurrent
64764-254-046476402540490 TABLET, FILM COATED in 1 BOTTLE (64764-254-04) 2013-01-250000-00-00NoNoCurrent
64764-254-0564764025405500 TABLET, FILM COATED in 1 BOTTLE (64764-254-05) 2013-01-250000-00-00NoNoCurrent