Nesina
These highlights do not include all the information needed to use NESINA safely and effectively. See full prescribing information for NESINA. NESINA (alogliptin) tablets, for oral use Initial U.S. Approval: 2013
Approved
Approval ID
a3768c7e-aa4c-44d3-bc53-43bb7346c0b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
Takeda Pharmaceuticals America, Inc.
DUNS: 039997266
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alogliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-250
Application NumberNDA022271
Product Classification
M
Marketing Category
C73594
G
Generic Name
alogliptin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (14)
ALOGLIPTIN BENZOATEActive
Quantity: 25 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
alogliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-125
Application NumberNDA022271
Product Classification
M
Marketing Category
C73594
G
Generic Name
alogliptin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (14)
ALOGLIPTIN BENZOATEActive
Quantity: 12.5 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
alogliptin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64764-625
Application NumberNDA022271
Product Classification
M
Marketing Category
C73594
G
Generic Name
alogliptin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (14)
ALOGLIPTIN BENZOATEActive
Quantity: 6.25 mg in 1 1
Code: EEN99869SC
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT