Home DailyMed ea14afe5-22bd-4b0a-bc02-88bccfca4be6 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:45:36
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 84e616aacf4f…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 19 · 724 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N201280-001 8883805 2025-11-26 Drug product 2014-12-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8883805*PED 2026-05-26 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 11033552 2027-05-04 Drug product 2021-07-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 12178819 2027-05-04 Drug product 2025-01-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 11033552*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8673927*PED 2027-11-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 10034877 2029-08-05 U-2347 2018-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 9486526 2029-08-05 U-1915 2016-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 10034877*PED 2030-02-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 9486526*PED 2030-02-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 11911388 2030-04-10 U-3854 2024-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8846695 2030-06-04 U-1503 Delist requested 2014-10-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8846695*PED 2030-12-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8853156 2031-03-05 U-1642 Drug product 2015-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 8853156*PED 2031-09-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 12364700 2037-06-08 U-4224 2025-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201280-001 12364700*PED 2037-12-08 Pediatric extension 84e616aacf4f…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 observed states.
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.