Home NDC 65649-003 Trulance
Product NDC 65649-003
11-digit product format 656490003
Labeler code 65649
Product ID 65649-003_154842e6-a919-ba71-e063-6394a90aebd4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Plecanatide
Dosage form TABLET
Route ORAL
Labeler Salix Pharmaceuticals Inc.
Application NDA208745
Marketing category NDA
Marketing start 2017-02-21
Substance PLECANATIDE
Active strength 3 mg/1
Pharmacologic classes Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]
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 N208745-001 TRULANCE PLECANATIDE 3MG TABLET / ORAL RLD, RS 2017-01-19
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 N208745-001 12146003 2034-06-05 Drug product 2024-11-25
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 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208745-001 TRULANCE 3MG TABLET / ORAL RLD, RS 2017-01-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 12 · 451 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 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208745-001 12146003 2034-06-05 Drug product 2024-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208745-001 12146003 2034-06-05 Drug product 2024-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9919024 2031-09-15 U-1999 2018-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9925231 2031-09-15 Drug product 2018-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 11319346 2032-03-01 Drug product 2022-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 9616097 2032-08-20 Drug product 2017-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 10011637 2034-06-05 Drug substance 2018-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 11142549 2034-06-05 Drug product 2021-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 11834521 2034-06-05 Drug product 2023-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208745-001 12146003 2034-06-05 Drug product 2024-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 7041786 2028-01-30 Drug substance 2017-02-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 9610321 2031-09-15 U-1999 2017-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 9610321 2031-09-15 U-2230 2017-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208745-001 9919024 2031-09-15 U-2230 2018-04-10 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Trulance
Brand name suffix Immediate release
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PLECANATIDE 3 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7IK8Z952OK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1873757 Internal RxNorm lookup 1873765 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 65649-003-01 TrulanceImmediate release 1 in 1 CARTON TABLET 1 15 65649-003-01 TrulanceImmediate release 1 in 1 BOTTLE TABLET 1 15 65649-003-03 TrulanceImmediate release 1 in 1 CARTON TABLET 1 15 65649-003-03 TrulanceImmediate release 3 in 1 BOTTLE TABLET 3 15 65649-003-07 TrulanceImmediate release 1 in 1 CARTON TABLET 1 15 65649-003-07 TrulanceImmediate release 7 in 1 BOTTLE TABLET 7 15 65649-003-30 TrulanceImmediate release 30 in 1 BOTTLE TABLET 30 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65649-003 TRULANCE IMMEDIATE RELEASE (PLECANATIDE) TABLET [SALIX PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 7 package rows 20240405_fe2895bf-71a6-493a-b0ca-e06b2dfefc82.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65649-003-01 65649000301 1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLE 1 bottle 2017-02-21 0000-00-00 No No Current 65649-003-03 65649000303 1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLE 1 bottle 2017-02-21 0000-00-00 No No Current 65649-003-07 65649000307 1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLE 1 bottle 2017-02-21 0000-00-00 Yes No Current 65649-003-30 65649000330 30 TABLET in 1 BOTTLE (65649-003-30) 30 tablet 2017-02-21 0000-00-00 No No Current