FDA.reportPublic FDA data

Alogliptin

Product NDC
45802-150
11-digit product format
458020150
Labeler code
45802
Product ID
45802-150_1287590b-abdf-470b-a611-dfb9bc93692a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alogliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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, 1368018, 1368034

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
36db81cb-9c11-39e1-6a1a-715fc2caa47cProduct 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
45802-150-65Alogliptin30 in 1 BOTTLETABLET, FILM COATED3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-150-65EA - Each45802-150f4667e0e-9444-4439-9957-61cfb8b8d49912016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-150ALOGLIPTIN TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]12Current NDC, Legacy NDC, 1 package rows20250501_b25f155a-1259-47c2-aa3b-7c1356e4c7f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368034alogliptin 12.5 MG Oral TabletPSNb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368006alogliptin 25 MG Oral TabletPSNb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368018alogliptin 6.25 MG Oral TabletPSNb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368034alogliptin 12.5 MG Oral TabletSCDb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368006alogliptin 25 MG Oral TabletSCDb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368018alogliptin 6.25 MG Oral TabletSCDb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368034alogliptin 12.5 MG (as alogliptin benzoate 17 MG) Oral TabletSYb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368006alogliptin 25 MG (as alogliptin benzoate 34 MG) Oral TabletSYb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368018alogliptin 6.25 MG (as alogliptin benzoate 8.5 MG) Oral TabletSYb25f155a-1259-47c2-aa3b-7c1356e4c7f612
1368006alogliptin 25 MG Oral TabletPSN38d30e4f-4212-4f7a-96b5-74b277b56cba6
1368006alogliptin 25 MG Oral TabletSCD38d30e4f-4212-4f7a-96b5-74b277b56cba6
1368006alogliptin 25 MG (as alogliptin benzoate 34 MG) Oral TabletSY38d30e4f-4212-4f7a-96b5-74b277b56cba6
1368006alogliptin 25 MG Oral TabletPSN4b007011-547a-498e-b8f6-34ea4ea00eb44
1368006alogliptin 25 MG Oral TabletSCD4b007011-547a-498e-b8f6-34ea4ea00eb44
1368006alogliptin 25 MG (as alogliptin benzoate 34 MG) Oral TabletSY4b007011-547a-498e-b8f6-34ea4ea00eb44
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 startMarketing endSampleExclude flagStatus
45802-150-654580201506530 TABLET, FILM COATED in 1 BOTTLE (45802-150-65) 2016-04-080000-00-00NoNoCurrent