OSENI

These highlights do not include all the information needed to use OSENI safely and effectively. See full prescribing information for OSENI. OSENI (alogliptin and pioglitazone) tablets, for oral useInitial U.S. Approval: 2013

Approved

Approval ID

4c619ed9-fe3e-4158-9938-80c6c3493d55

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 4, 2023

Manufacturers

FDA

Takeda Pharmaceuticals America, Inc.

DUNS: 039997266

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

alogliptin and pioglitazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64764-254

Application NumberNDA022426

Product Classification

Marketing Category

C73594

Generic Name

alogliptin and pioglitazone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2023

FDA Product Classification

INGREDIENTS (17)

ALOGLIPTIN BENZOATEActive

Quantity: 25 mg in 1 1

Code: EEN99869SC

Classification: ACTIM

PIOGLITAZONE HYDROCHLORIDEActive

Quantity: 45 mg in 1 1

Code: JQT35NPK6C

Classification: ACTIM

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

alogliptin and pioglitazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64764-253

Application NumberNDA022426

Product Classification

Marketing Category

C73594

Generic Name

alogliptin and pioglitazone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2023

FDA Product Classification

INGREDIENTS (18)

ALOGLIPTIN BENZOATEActive

Quantity: 25 mg in 1 1

Code: EEN99869SC

Classification: ACTIM

PIOGLITAZONE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: JQT35NPK6C

Classification: ACTIM

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

alogliptin and pioglitazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64764-251

Application NumberNDA022426

Product Classification

Marketing Category

C73594

Generic Name

alogliptin and pioglitazone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2023

FDA Product Classification

INGREDIENTS (17)

ALOGLIPTIN BENZOATEActive

Quantity: 25 mg in 1 1

Code: EEN99869SC

Classification: ACTIM

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

PIOGLITAZONE HYDROCHLORIDEActive

Quantity: 15 mg in 1 1

Code: JQT35NPK6C

Classification: ACTIM

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

alogliptin and pioglitazone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code64764-123

Application NumberNDA022426

Product Classification

Marketing Category

C73594

Generic Name

alogliptin and pioglitazone

Product Specifications

Route of AdministrationORAL

Effective DateDecember 4, 2023

FDA Product Classification

INGREDIENTS (19)

ALOGLIPTIN BENZOATEActive

Quantity: 12.5 mg in 1 1

Code: EEN99869SC

Classification: ACTIM

PIOGLITAZONE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: JQT35NPK6C

Classification: ACTIM

HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive

Code: UKE75GEA7F

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYGLYCERYL-10 OLEATEInactive

Code: 55C81W76DH

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZ

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

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OSENI

Products 4

alogliptin and pioglitazone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

alogliptin and pioglitazone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

alogliptin and pioglitazone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (17)

alogliptin and pioglitazone

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

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