FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201280-001TRADJENTALINAGLIPTIN5MGTABLET / ORALABRLD, RS2011-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N201280-001AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201280-00188838052025-11-26Drug product2014-12-09
N201280-0018883805*PED2026-05-26Pediatric extension
N201280-001110335522027-05-04Drug product2021-07-09
N201280-001121788192027-05-04Drug product2025-01-24
N201280-00186739272027-05-04U-1503Delist requested2014-04-15
N201280-00111033552*PED2027-11-04Pediatric extension
N201280-0018673927*PED2027-11-04Pediatric extension
N201280-001100348772029-08-05U-23472018-08-10
N201280-00194865262029-08-05U-19152016-11-18
N201280-00110034877*PED2030-02-05Pediatric extension
N201280-0019486526*PED2030-02-05Pediatric extension
N201280-001119113882030-04-10U-38542024-03-25
N201280-00188466952030-06-04U-1503Delist requested2014-10-21
N201280-0018846695*PED2030-12-04Pediatric extension
N201280-00188531562031-03-05U-1642Drug product2015-01-23
N201280-0018853156*PED2031-09-05Pediatric extension
N201280-001123647002037-06-08U-42242025-07-31
N201280-00112364700*PED2037-12-08Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N201280-001M-2952026-06-20
N201280-001PED2026-12-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N201280-001TRADJENTA5MGTABLET / ORALABRLD, RS2011-05-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N201280-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N201280-00188838052025-11-26Drug product2014-12-09a50c72e98297…
2026-08-01 22:54:322026-06N201280-0018883805*PED2026-05-26Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-001110335522027-05-04Drug product2021-07-09a50c72e98297…
2026-08-01 22:54:322026-06N201280-001121788192027-05-04Drug product2025-01-24a50c72e98297…
2026-08-01 22:54:322026-06N201280-00186739272027-05-04U-1503Delist requested2014-04-15a50c72e98297…
2026-08-01 22:54:322026-06N201280-00111033552*PED2027-11-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-0018673927*PED2027-11-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-001100348772029-08-05U-23472018-08-10a50c72e98297…
2026-08-01 22:54:322026-06N201280-00194865262029-08-05U-19152016-11-18a50c72e98297…
2026-08-01 22:54:322026-06N201280-00110034877*PED2030-02-05Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-0019486526*PED2030-02-05Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-001119113882030-04-10U-38542024-03-25a50c72e98297…
2026-08-01 22:54:322026-06N201280-00188466952030-06-04U-1503Delist requested2014-10-21a50c72e98297…
2026-08-01 22:54:322026-06N201280-0018846695*PED2030-12-04Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-00188531562031-03-05U-1642Drug product2015-01-23a50c72e98297…
2026-08-01 22:54:322026-06N201280-0018853156*PED2031-09-05Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201280-001123647002037-06-08U-42242025-07-31a50c72e98297…
2026-08-01 22:54:322026-06N201280-00112364700*PED2037-12-08Pediatric extensiona50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N201280-001M-2952026-06-20a50c72e98297…
2026-08-01 22:54:322026-06N201280-001PED2026-12-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TradjentaLINAGLIPTINCardinal Health 107, LLCdfe327e8-f6ab-41e5-bdef-d520118cd83a2025-08-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 201280
application number: NDA201280
TradjentaLINAGLIPTINBoehringer Ingelheim Pharmaceuticals, Inc.c797ea5c-cab7-494b-9044-27eba0cfe40f2025-03-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 201280
application number: NDA201280
ndc (product): 0597-0140
TradjentaLINAGLIPTINA-S Medication Solutionsb1da67d4-51e0-41b7-9fe1-7f38c0d1baa12024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 201280
application number: NDA201280

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X29ZEJ4R2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1100702Internal RxNorm lookup
1100706Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c797ea5c-cab7-494b-9044-27eba0cfe40fAvailable on FDA.report

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
linagliptinACTIVE INGREDIENT3X29ZEJ4R2TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]20
linagliptinACTIVE MOIETY3X29ZEJ4R2TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]20
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
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