Lialda

Product NDC
0179-0142
11-digit product format
001790142
Labeler code
0179
Product ID
0179-0142_7bc2147d-1c6b-5a72-e053-2a91aa0a8140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
KAISER FOUNDATION HOSPITA
Application
NDA022000
Marketing category
NDA
Marketing start
2013-12-06
Marketing end
2019-03-31
Substance
MESALAMINE
Active strength
1 g/1
Pharmacologic classes
Aminosalicylate
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct0179-0142DDiscontinued by firm2026-08-11
excluded packagepackage0179-01420179-0142-70DDiscontinued by firm2026-08-11

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 packagepackage0179-0142-70d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0179-0142-70f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0179-0142-702ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0179-0142-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0179-0142-70cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0179-0142-70cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0179-0142-70302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0179-0142-70ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0179-0142-700efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0179-0142-70ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0179-0142-70367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0179-0142-70557ba5c1ecfa…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
N022000-001LIALDAMESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N022000-001AB

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 UTC2026-02N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-163f01610625f2…
2019-09-15 20:21 UTC2019-09N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022000-001LIALDA1.2GMTABLET, DELAYED RELEASE / ORALABRLD, RS2007-01-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022000-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022000-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022000-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022000-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022000-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022000-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022000-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022000-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022000-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022000-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022000-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022000-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022000-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022000-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022000-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022000-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022000-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022000-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022000-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022000-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022000-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022000-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022000-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022000-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022000-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022000-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022000-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022000-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022000-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022000-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022000-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022000-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022000-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022000-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022000-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022000-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022000-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022000-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022000-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022000-001AB1cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N022000-00167737202020-06-08Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N022000-00167737202020-06-08Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022000-00167737202020-06-08Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022000-00167737202020-06-08Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N022000-00167737202020-06-08Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N022000-00167737202020-06-08Drug productea99ee380514…

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 ZIP2022-06N022000-001NPP2023-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022000-001NPP2023-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022000-001NPP2023-06-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022000-001NPP2023-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022000-001NPP2023-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022000-001NPP2023-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N022000-001NPP2023-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022000-001NPP2023-06-268869cabd3fbd…
2023-12-20 04:57 UTC2023-12N022000-001NPP2023-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022000-001NPP2023-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022000-001NPP2023-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022000-001NPP2023-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022000-001NPP2023-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N022000-001NPP2023-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N022000-001NPP2023-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022000-001NPP2023-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022000-001NPP2023-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022000-001NPP2023-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022000-001NPP2023-06-26cb3db0bc1861…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LialdaMESALAMINETakeda Pharmaceuticals America, Inc.3098a080-be86-4265-9818-7fc4beab77b72026-03-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 022000
application number: NDA022000
MesalamineMESALAMINETakeda Pharmaceuticals America, Inc.4e3b6325-a5bf-4c47-931c-142c0e4d7c3a2025-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 022000
application number: NDA022000