FDA.reportPublic FDA data

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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4168-12023-01-30C16284748780-1f386c649-d0d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MESALAMINE DELAYED-RELEASE TABLETS. MESALAMINE Delayed-release Tablets, for oral use Initial U.S. Approval: 1987

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

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