Trulance

Product NDC
70194-003
11-digit product format
701940003
Labeler code
70194
Product ID
70194-003_c57a7f88-c77b-4921-b601-af7e68903435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Plecanatide
Dosage form
TABLET
Route
ORAL
Labeler
Synergy Pharmaceuticals Inc.
Application
NDA208745
Marketing category
NDA
Marketing start
2017-02-21
Marketing end
0000-00-00
Substance
PLECANATIDE
Active strength
3 mg/1
Pharmacologic classes
Guanylate Cyclase-C Agonist [EPC],Guanylate Cyclase Activators [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70194-003DDiscontinued by firm2026-08-03
excluded packagepackage70194-00370194-003-30DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70194-003-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70194-003-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70194-003-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70194-003-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70194-003-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70194-003-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70194-003-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70194-003-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70194-003-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70194-003-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70194-003-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70194-003-30557ba5c1ecfa…9c80585c8c6e…

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
N208745-001TRULANCEPLECANATIDE3MGTABLET / ORALRLD, RS2017-01-19

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208745-00170417862028-01-30Drug substance2017-02-14
N208745-00196103212031-09-15U-19992017-05-01
N208745-00196103212031-09-15U-22302017-05-01
N208745-00199190242031-09-15U-19992018-04-10
N208745-00199190242031-09-15U-22302018-04-10
N208745-00199252312031-09-15Drug product2018-04-10
N208745-001113193462032-03-01Drug product2022-05-11
N208745-00196160972032-08-20Drug product2017-05-01
N208745-001100116372034-06-05Drug substance2018-07-19
N208745-001111425492034-06-05Drug product2021-10-25
N208745-001118345212034-06-05Drug product2023-12-14
N208745-001121460032034-06-05Drug product2024-11-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208745-001TRULANCE3MGTABLET / ORALRLD, RS2017-01-19cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 12 · 451 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208745-00170417862028-01-30Drug substance2017-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-00196103212031-09-15U-19992017-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-00196103212031-09-15U-22302017-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-00199190242031-09-15U-22302018-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-00199190242031-09-15U-19992018-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-00199252312031-09-15Drug product2018-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-001113193462032-03-01Drug product2022-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-00196160972032-08-20Drug product2017-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-001100116372034-06-05Drug substance2018-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-001111425492034-06-05Drug product2021-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-001118345212034-06-05Drug product2023-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208745-001121460032034-06-05Drug product2024-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00170417862028-01-30Drug substance2017-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00196103212031-09-15U-19992017-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00196103212031-09-15U-22302017-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00199190242031-09-15U-22302018-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00199190242031-09-15U-19992018-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00199252312031-09-15Drug product2018-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-001113193462032-03-01Drug product2022-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-00196160972032-08-20Drug product2017-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-001100116372034-06-05Drug substance2018-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-001111425492034-06-05Drug product2021-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-001118345212034-06-05Drug product2023-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208745-001121460032034-06-05Drug product2024-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208745-00170417862028-01-30Drug substance2017-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-00196103212031-09-15U-19992017-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-00196103212031-09-15U-22302017-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-00199190242031-09-15U-22302018-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-00199190242031-09-15U-19992018-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-00199252312031-09-15Drug product2018-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-001113193462032-03-01Drug product2022-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-00196160972032-08-20Drug product2017-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-001100116372034-06-05Drug substance2018-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-001111425492034-06-05Drug product2021-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-001118345212034-06-05Drug product2023-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208745-001121460032034-06-05Drug product2024-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208745-00170417862028-01-30Drug substance2017-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208745-00196103212031-09-15U-19992017-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208745-00196103212031-09-15U-22302017-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208745-00199190242031-09-15U-22302018-04-10fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208745-001NCE2022-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208745-001NCE2022-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208745-001NCE2022-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208745-001I-7642021-01-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N208745-001NCE2022-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208745-001NCE2022-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208745-001I-7642021-01-24782e0a99824c…
2021-12-28 21:50 UTC2021-12N208745-001NCE2022-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208745-001I-7642021-01-2487673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208745-001NCE2022-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N208745-001I-7642021-01-245aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N208745-001NCE2022-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208745-001I-7642021-01-248869cabd3fbd…
2020-12-22 03:56 UTC2020-12N208745-001NCE2022-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208745-001I-7642021-01-24c0c555d07b60…
2020-11-12 02:37 UTC2020-11N208745-001NCE2022-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208745-001I-7642021-01-243f01610625f2…
2019-12-14 00:12 UTC2019-12N208745-001NCE2022-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09N208745-001I-7642021-01-24b00525d2431f…
2019-09-15 20:21 UTC2019-09N208745-001NCE2022-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N208745-001I-7642021-01-24ea99ee380514…
2019-07-19 19:46 UTC2019-07N208745-001NCE2022-01-19ea99ee380514…
2023-01-26 05:58 UTC2023-01N208745-001NCE2022-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208745-001NCE2022-01-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208745-001NCE2022-01-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208745-001NCE2022-01-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208745-001NCE2022-01-19cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70194-003-30EA - Each70194-00340bdd186-c076-4915-9e86-9c44db1a3c3412017-03-06

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trulance Immediate releasePLECANATIDESalix Pharmaceuticals Inc.fe2895bf-71a6-493a-b0ca-e06b2dfefc822024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208745
application number: NDA208745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70194-003-30701940003301 BLISTER PACK in 1 CARTON (70194-003-30) > 30 TABLET in 1 BLISTER PACK1 blister pack2017-02-210000-00-00NoNoCurrent