mesalamine

Product NDC
50090-3497
11-digit product format
500903497
Labeler code
50090
Product ID
50090-3497_bfb7ddc2-5d55-4434-a73a-fa720e9ef751
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA021830
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-08-01
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
800 mg/1
Pharmacologic classes
Aminosalicylate [EPC],Aminosalicylic Acids [CS]
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 productproduct50090-3497IInactivated by FDA2026-08-17
excluded packagepackage50090-349750090-3497-0IInactivated by FDA2026-08-17

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 · 30 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 packagepackage50090-3497-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3497-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3497-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3497-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3497-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3497-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3497-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3497-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3497-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3497-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3497-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3497-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3497-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3497-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3497-01332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021830-001ASACOL HDMESALAMINE800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALABRLD, RS2008-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N021830-001ASACOL HD800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2008-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021830-001ASACOL HD800MGTABLET, DELAYED RELEASE / ORALRLD2008-05-29e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04N021830-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021830-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021830-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021830-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021830-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021830-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021830-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021830-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021830-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021830-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021830-001AB1ea99ee380514…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021830-00168936622021-11-15U-141Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021830-00185803022021-11-15Drug product2013-11-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021830-00190894922021-11-15Drug product2015-09-2274a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021830-00168936622021-11-15U-141Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021830-00185803022021-11-15Drug product2013-11-13782e0a99824c…
2021-12-28 21:50 UTC2021-12N021830-00190894922021-11-15Drug product2015-09-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-00168936622021-11-15U-141Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-00185803022021-11-15Drug product2013-11-1387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021830-00190894922021-11-15Drug product2015-09-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N021830-00168936622021-11-15U-141Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021830-00185803022021-11-15Drug product2013-11-135aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021830-00190894922021-11-15Drug product2015-09-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021830-00168936622021-11-15U-141Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021830-00185803022021-11-15Drug product2013-11-138869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021830-00190894922021-11-15Drug product2015-09-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021830-00168936622021-11-15U-141Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021830-00185803022021-11-15Drug product2013-11-13c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021830-00190894922021-11-15Drug product2015-09-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021830-00168936622021-11-15U-141Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021830-00185803022021-11-15Drug product2013-11-133f01610625f2…
2019-12-14 00:12 UTC2019-12N021830-00190894922021-11-15Drug product2015-09-223f01610625f2…
2019-09-15 20:21 UTC2019-09N021830-00168936622021-11-15U-141Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021830-00185803022021-11-15Drug product2013-11-13b00525d2431f…
2019-09-15 20:21 UTC2019-09N021830-00190894922021-11-15Drug product2015-09-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N021830-00168936622021-11-15U-141Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021830-00185803022021-11-15Drug product2013-11-13ea99ee380514…
2019-07-19 19:46 UTC2019-07N021830-00190894922021-11-15Drug product2015-09-22ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c403bb07-2e2f-647c-b633-3f06ae7ddbe3Product name320260128
37997c2c-8686-b078-51f1-fb15da0c0a1cProduct name620260127
97851e97-0a12-4d74-aaa4-9583fe070304Product name220250318
194d5e54-52c4-1a5e-51c5-1224f8e44e49Product name520250317
4b8d62b1-86bf-0c4e-9f22-ebffb45e4564Product name520240514
f6c01aa7-7e2c-4709-91b6-fc6ece37a7b3Product name120230124
a4dbd90c-f616-c999-40d7-60da88952163Product name220190802
77831c26-5062-ed63-fc15-a07600377b5bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3497-0mesalamine180 in 1 BOTTLETABLET, DELAYED RELEASE1807

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3497MESALAMINE TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210305_25998d2b-4260-4cf8-8a54-a15ee3292da4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833234mesalamine 800 MG Delayed Release Oral TabletPSN25998d2b-4260-4cf8-8a54-a15ee3292da47
833234mesalamine 800 MG Delayed Release Oral TabletSCD25998d2b-4260-4cf8-8a54-a15ee3292da47
833234mesalazine 800 MG Delayed Release Oral TabletSY25998d2b-4260-4cf8-8a54-a15ee3292da47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3497-050090349700180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3497-0) 2018-06-250000-00-00NoNoCurrent