Alogliptin

Product NDC
63629-4946
11-digit product format
636294946
Labeler code
63629
Product ID
63629-4946_92219b66-aacf-4ddc-9320-9ea8f620ab8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alogliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA022271
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-04-08
Substance
ALOGLIPTIN BENZOATE
Active strength
25 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
Alogliptin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOGLIPTIN BENZOATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEEN99869SC
Rxcui1368006

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
63629-4946-1Alogliptin30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4946ALOGLIPTIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 1 package rows20250130_f2ad6d21-8060-42c7-8b3f-ad80085dc022.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368006alogliptin 25 MG Oral TabletPSNf2ad6d21-8060-42c7-8b3f-ad80085dc0221
1368006alogliptin 25 MG Oral TabletSCDf2ad6d21-8060-42c7-8b3f-ad80085dc0221
1368006alogliptin 25 MG (as alogliptin benzoate 34 MG) Oral TabletSYf2ad6d21-8060-42c7-8b3f-ad80085dc0221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-4946-16362949460130 TABLET, FILM COATED in 1 BOTTLE (63629-4946-1) 2025-01-28NoNoHistorical