Nesina

Product NDC
64764-125
11-digit product format
647640125
Labeler code
64764
Product ID
64764-125_225103de-a3f2-47ee-bebb-4aa24b16aab4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alogliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA022271
Marketing category
NDA
Marketing start
2013-01-25
Substance
ALOGLIPTIN BENZOATE
Active strength
12.5 mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOGLIPTIN BENZOATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEEN99869SC
Rxcui1368006, 1368012, 1368018, 1368020, 1368034, 1368036

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36db81cb-9c11-39e1-6a1a-715fc2caa47cProduct name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-125-02Nesina4 in 1 TRAYTABLET, FILM COATED422
64764-125-02Nesina1 in 1 CARTONTABLET, FILM COATED122
64764-125-30Nesina30 in 1 BOTTLETABLET, FILM COATED3022
64764-125-50Nesina500 in 1 BOTTLETABLET, FILM COATED50022
64764-125-90Nesina90 in 1 BOTTLETABLET, FILM COATED9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-125-30EA - Each64764-125a4e9e455-70d3-4600-ba61-03957cd0405412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALOGLIPTIN BENZOATEACTIVE INGREDIENTEEN99869SCNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
ALOGLIPTINACTIVE MOIETYJHC049LO86NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ANESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71ONESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-125NESINA (ALOGLIPTIN) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]22Current NDC, Legacy NDC, 5 package rows20250322_a3768c7e-aa4c-44d3-bc53-43bb7346c0b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368034alogliptin 12.5 MG Oral TabletPSNa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368006alogliptin 25 MG Oral TabletPSNa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368018alogliptin 6.25 MG Oral TabletPSNa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368036Nesina 12.5 MG Oral TabletPSNa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368012Nesina 25 MG Oral TabletPSNa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368020Nesina 6.25 MG Oral TabletPSNa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368036alogliptin 12.5 MG Oral Tablet [Nesina]SBDa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368012alogliptin 25 MG Oral Tablet [Nesina]SBDa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368020alogliptin 6.25 MG Oral Tablet [Nesina]SBDa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368034alogliptin 12.5 MG Oral TabletSCDa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368006alogliptin 25 MG Oral TabletSCDa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368018alogliptin 6.25 MG Oral TabletSCDa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368034alogliptin 12.5 MG (as alogliptin benzoate 17 MG) Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368006alogliptin 25 MG (as alogliptin benzoate 34 MG) Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368018alogliptin 6.25 MG (as alogliptin benzoate 8.5 MG) Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368036Nesina 12.5 MG (as alogliptin benzoate 17 MG) Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368036Nesina 12.5 MG Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368012Nesina 25 MG (as alogliptin benzoate 34 MG) Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368012Nesina 25 MG Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368020Nesina 6.25 MG (as alogliptin benzoate 8.5 MG) Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022
1368020Nesina 6.25 MG Oral TabletSYa3768c7e-aa4c-44d3-bc53-43bb7346c0b022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-125-02647640125024 CARTON in 1 TRAY (64764-125-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK4 carton2013-01-250000-00-00NoNoCurrent
64764-125-306476401253030 TABLET, FILM COATED in 1 BOTTLE (64764-125-30) 2013-01-250000-00-00NoNoCurrent
64764-125-5064764012550500 TABLET, FILM COATED in 1 BOTTLE (64764-125-50) 2013-01-250000-00-00NoNoCurrent
64764-125-906476401259090 TABLET, FILM COATED in 1 BOTTLE (64764-125-90) 2013-01-250000-00-00NoNoCurrent