Tradjenta

Product NDC
55154-0410
11-digit product format
551540410
Labeler code
55154
Product ID
55154-0410_195b6992-7ffb-4fb1-a959-74345e5060f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linagliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
NDA201280
Marketing category
NDA
Marketing start
2011-05-09
Substance
LINAGLIPTIN
Active strength
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
Tradjenta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINAGLIPTIN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X29ZEJ4R2
Rxcui1100702, 1100706

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b15b11c6-be06-b86a-2026-0a2ad3876555Product name320250429
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
24acbc89-fd6a-458c-aa62-a3485b119bedProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-0410-8Tradjenta2640 in 1 BOTTLE, PLASTICTABLET, FILM COATED264012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-0410-8EA - Each55154-041056d35594-82e2-47b7-b1f4-be6aae09ea4c12025-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
linagliptinACTIVE INGREDIENT3X29ZEJ4R2TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1
linagliptinACTIVE MOIETY3X29ZEJ4R2TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0410TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]11Current NDC, Legacy NDC, 1 package rows20250503_dfe327e8-f6ab-41e5-bdef-d520118cd83a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100702linagliptin 5 MG Oral TabletPSNdfe327e8-f6ab-41e5-bdef-d520118cd83a12
1100706Tradjenta 5 MG Oral TabletPSNdfe327e8-f6ab-41e5-bdef-d520118cd83a12
1100706linagliptin 5 MG Oral Tablet [Tradjenta]SBDdfe327e8-f6ab-41e5-bdef-d520118cd83a12
1100702linagliptin 5 MG Oral TabletSCDdfe327e8-f6ab-41e5-bdef-d520118cd83a12
1100706Tradjenta 5 MG Oral TabletSYdfe327e8-f6ab-41e5-bdef-d520118cd83a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-0410-8551540410082640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0410-8) 2011-05-090000-00-00NoNoCurrent