mesalamine

Product NDC
50090-4168
11-digit product format
500904168
Labeler code
50090
Product ID
50090-4168_ac3fee9b-0341-4dad-9e69-f146fb6779a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091640
Marketing category
ANDA
Marketing start
2018-06-25
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
1 g/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 productproduct50090-4168IInactivated by FDA2026-08-11
excluded packagepackage50090-416850090-4168-1IInactivated by FDA2026-08-11

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 · 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 packagepackage50090-4168-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4168-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4168-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4168-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4168-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4168-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4168-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4168-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4168-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4168-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4168-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4168-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4168-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4168-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4168-11332a3947898…d4bfe170f9cd…

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
A091640-001MESALAMINEMESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091640-001AB

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 UTC2026-02A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091640-001MESALAMINE1.2GMTABLET, DELAYED RELEASE / ORALAB2017-06-05cb3db0bc1861…

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 UTC2026-02A091640-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091640-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091640-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091640-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091640-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091640-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091640-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091640-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091640-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091640-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091640-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091640-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091640-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091640-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091640-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091640-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091640-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091640-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091640-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091640-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091640-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091640-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091640-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091640-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091640-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091640-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091640-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091640-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091640-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091640-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091640-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091640-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091640-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091640-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091640-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091640-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091640-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091640-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091640-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091640-001AB1cb3db0bc1861…

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
50090-4168-1mesalamine120 in 1 BOTTLETABLET, DELAYED RELEASE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4168MESALAMINE TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210304_dd685633-e1ce-48d1-a47a-5c08dc39ee31.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mesalamineMESALAMINEMajor Pharmaceuticals14ac4435-903b-41f5-a3c4-8c73de3e4cef2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091640
application number: ANDA091640
mesalamineMESALAMINEZydus Lifesciences Limited29c0dd58-d2cf-40fa-bc32-0eab619373312024-11-30Exact identifier
application applno (ANDA): 091640
application number: ANDA091640
MesalamineMESALAMINEAmerican Health Packaging77140634-9f32-40ca-8c83-9fcc3e373c162024-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091640
application number: ANDA091640
mesalamineMESALAMINEGolden State Medical Supply, Inc.170657d1-1f32-f036-e063-6294a90a4ed42024-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091640
application number: ANDA091640
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.533bfaf5-0add-4b49-a4f2-ddea2b83f65d2023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091640
application number: ANDA091640

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686429mesalamine 1.2 GM Delayed Release Oral Tablet, Once-DailyPSNdd685633-e1ce-48d1-a47a-5c08dc39ee311
686429mesalamine 1200 MG Delayed Release Oral TabletSCDdd685633-e1ce-48d1-a47a-5c08dc39ee311
686429mesalazine 1.2 GM Delayed Release Oral TabletSYdd685633-e1ce-48d1-a47a-5c08dc39ee311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4168-150090416801120 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4168-1) 2019-06-050000-00-00NoNoCurrent