Tradjenta

Product NDC
0597-0140
11-digit product format
005970140
Labeler code
0597
Product ID
0597-0140_80d5d700-e711-462e-b291-3684a78d00b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linagliptin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
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
0597-0140-30Tradjenta30 in 1 BOTTLETABLET, FILM COATED3032
0597-0140-61Tradjenta1 in 1 BLISTER PACKTABLET, FILM COATED132
0597-0140-61Tradjenta100 in 1 CARTONTABLET, FILM COATED10032
0597-0140-70Tradjenta1 in 1 BLISTER PACKTABLET, FILM COATED132
0597-0140-70Tradjenta7 in 1 CARTONTABLET, FILM COATED732
0597-0140-90Tradjenta90 in 1 BOTTLETABLET, FILM COATED9032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0140-30EA - Each0597-0140ea14afe5-22bd-4b0a-bc02-88bccfca4be612012-07-24
0597-0140-61EA - Each0597-01405c6d1e79-e4bc-4510-b89a-87d3f5ac305712012-07-24
0597-0140-90EA - Each0597-0140f0fe977b-e10c-4559-873e-d4642012705e12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0140TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]32Current NDC, Legacy NDC, 6 package rows20250327_c797ea5c-cab7-494b-9044-27eba0cfe40f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1100702linagliptin 5 MG Oral TabletPSNc797ea5c-cab7-494b-9044-27eba0cfe40f32
1100706Tradjenta 5 MG Oral TabletPSNc797ea5c-cab7-494b-9044-27eba0cfe40f32
1100706linagliptin 5 MG Oral Tablet [Tradjenta]SBDc797ea5c-cab7-494b-9044-27eba0cfe40f32
1100702linagliptin 5 MG Oral TabletSCDc797ea5c-cab7-494b-9044-27eba0cfe40f32
1100706Tradjenta 5 MG Oral TabletSYc797ea5c-cab7-494b-9044-27eba0cfe40f32
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
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0140-300059701403030 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30) 2011-05-090000-00-00NoNoCurrent
0597-0140-6100597014061100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2011-05-090000-00-00NoNoCurrent
0597-0140-70005970140707 BLISTER PACK in 1 CARTON (0597-0140-70) / 1 TABLET, FILM COATED in 1 BLISTER PACK7 blister pack2011-05-092026-08-31YesNoCurrent
0597-0140-900059701409090 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90) 2011-05-090000-00-00NoNoCurrent