Home NDC 50090-4383 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 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-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 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201280-001 TRADJENTA 5MG TABLET / ORAL AB RLD, RS 2011-05-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 688 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 11033552 2027-05-04 Drug product 2021-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 12178819 2027-05-04 Drug product 2025-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8673927 2027-05-04 U-1503 Delist requested 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 11033552*PED 2027-11-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8673927*PED 2027-11-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 10034877 2029-08-05 U-2347 2018-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 9486526 2029-08-05 U-1915 2016-11-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 10034877*PED 2030-02-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 9486526*PED 2030-02-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 11911388 2030-04-10 U-3854 2024-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8846695 2030-06-04 U-1503 Delist requested 2014-10-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8846695*PED 2030-12-04 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8853156 2031-03-05 U-1642 Drug product 2015-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 8853156*PED 2031-09-05 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 12364700 2037-06-08 U-4224 2025-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201280-001 12364700*PED 2037-12-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201280-001 7407955 2025-05-02 Drug substance, Drug product 2011-05-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201280-001 7407955*PED 2025-11-02 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 74 observed states.
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.
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 50090-4383-0 Tradjenta 90 in 1 BOTTLE TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4383 TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 8 Current NDC, Legacy NDC, 1 package rows 20240123_b1da67d4-51e0-41b7-9fe1-7f38c0d1baa1.zip
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 50090-4383-0 50090438300 90 TABLET, FILM COATED in 1 BOTTLE (50090-4383-0) 2019-06-24 0000-00-00 No No Current