FDA.reportPublic FDA data

Alogliptin

Product NDC
71610-300
11-digit product format
716100300
Labeler code
71610
Product ID
71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alogliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
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
71610-300-09Alogliptin9000 in 1 BOTTLETABLET, FILM COATED90004
71610-300-18Alogliptin3000 in 1 BOTTLETABLET, FILM COATED30004
71610-300-60Alogliptin90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-300-09EA - Each71610-300290c72f2-7fb5-40ad-b00c-c69734b99f7e12019-08-06
71610-300-18EA - Each71610-300859b923b-9e79-498c-bdf4-e06edf3c7d0912023-12-05
71610-300-60EA - Each71610-3008e427135-6e28-44db-b855-de487039fa5d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-300ALOGLIPTIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 3 package rows20230203_4b007011-547a-498e-b8f6-34ea4ea00eb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-300-09716100300099000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09) 2019-07-030000-00-00NoNoCurrent
71610-300-18716100300183000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18) 2022-01-25NoNoCurrent
71610-300-607161003006090 TABLET, FILM COATED in 1 BOTTLE (71610-300-60) 2023-02-02NoNoCurrent