Tradjenta

Product NDC
50090-4383
11-digit product format
500904383
Labeler code
50090
Product ID
50090-4383_706b12b0-f37f-4e9c-9776-038d78f4b9de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linagliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-4383-0Tradjenta90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4383-0EA - Each50090-438328e8e96a-401d-4c26-b44b-81dea898832712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4383TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 1 package rows20240123_b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100702linagliptin 5 MG Oral TabletPSNb1da67d4-51e0-41b7-9fe1-7f38c0d1baa18
1100706Tradjenta 5 MG Oral TabletPSNb1da67d4-51e0-41b7-9fe1-7f38c0d1baa18
1100706linagliptin 5 MG Oral Tablet [Tradjenta]SBDb1da67d4-51e0-41b7-9fe1-7f38c0d1baa18
1100702linagliptin 5 MG Oral TabletSCDb1da67d4-51e0-41b7-9fe1-7f38c0d1baa18
1100706Tradjenta 5 MG Oral TabletSYb1da67d4-51e0-41b7-9fe1-7f38c0d1baa18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4383-05009043830090 TABLET, FILM COATED in 1 BOTTLE (50090-4383-0) 2019-06-240000-00-00NoNoCurrent