Home NDC 55154-0410 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201280-001 TRADJENTA LINAGLIPTIN 5MG TABLET / ORAL AB RLD, RS 2011-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201280-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N201280-001 8883805 2025-11-26 Drug product 2014-12-09 N201280-001 8883805*PED 2026-05-26 Pediatric extension N201280-001 11033552 2027-05-04 Drug product 2021-07-09 N201280-001 12178819 2027-05-04 Drug product 2025-01-24 N201280-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 N201280-001 11033552*PED 2027-11-04 Pediatric extension N201280-001 8673927*PED 2027-11-04 Pediatric extension N201280-001 10034877 2029-08-05 U-2347 2018-08-10 N201280-001 9486526 2029-08-05 U-1915 2016-11-18 N201280-001 10034877*PED 2030-02-05 Pediatric extension N201280-001 9486526*PED 2030-02-05 Pediatric extension N201280-001 11911388 2030-04-10 U-3854 2024-03-25 N201280-001 8846695 2030-06-04 U-1503 Delist requested 2014-10-21 N201280-001 8846695*PED 2030-12-04 Pediatric extension N201280-001 8853156 2031-03-05 U-1642 Drug product 2015-01-23 N201280-001 8853156*PED 2031-09-05 Pediatric extension N201280-001 12364700 2037-06-08 U-4224 2025-07-31 N201280-001 12364700*PED 2037-12-08 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N201280-001 M-295 2026-06-20 N201280-001 PED 2026-12-20
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201280-001 TRADJENTA 5MG TABLET / ORAL RLD, RS 2011-05-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 706 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N201280-001 8883805 2025-11-26 Drug product 2014-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8883805*PED 2026-05-26 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 11033552 2027-05-04 Drug product 2021-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 12178819 2027-05-04 Drug product 2025-01-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 11033552*PED 2027-11-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8673927*PED 2027-11-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 10034877 2029-08-05 U-2347 2018-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 9486526 2029-08-05 U-1915 2016-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 10034877*PED 2030-02-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 9486526*PED 2030-02-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 11911388 2030-04-10 U-3854 2024-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8846695 2030-06-04 U-1503 Delist requested 2014-10-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8846695*PED 2030-12-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8853156 2031-03-05 U-1642 Drug product 2015-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 8853156*PED 2031-09-05 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 12364700 2037-06-08 U-4224 2025-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201280-001 12364700*PED 2037-12-08 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201280-001 8883805 2025-11-26 Drug product 2014-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8883805*PED 2026-05-26 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 11033552 2027-05-04 Drug product 2021-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 12178819 2027-05-04 Drug product 2025-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 11033552*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8673927*PED 2027-11-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 10034877 2029-08-05 U-2347 2018-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 9486526 2029-08-05 U-1915 2016-11-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 10034877*PED 2030-02-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 9486526*PED 2030-02-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 11911388 2030-04-10 U-3854 2024-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8846695 2030-06-04 U-1503 Delist requested 2014-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8846695*PED 2030-12-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8853156 2031-03-05 U-1642 Drug product 2015-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 8853156*PED 2031-09-05 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 12364700 2037-06-08 U-4224 2025-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201280-001 12364700*PED 2037-12-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 7407955 2025-05-02 Drug substance, Drug product 2011-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 7407955*PED 2025-11-02 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8883805 2025-11-26 Drug product 2014-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8883805*PED 2026-05-26 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tradjenta
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINAGLIPTIN 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X29ZEJ4R2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1100702 Internal RxNorm lookup 1100706 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-0410-8 Tradjenta 2640 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 2640 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-0410 TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 11 Current NDC, Legacy NDC, 1 package rows 20250503_dfe327e8-f6ab-41e5-bdef-d520118cd83a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55154-0410-8 55154041008 2640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0410-8) 2011-05-09 0000-00-00 No No Current