FDA.reportPublic FDA data

montelukast sodium

Product NDC
50090-5774
11-digit product format
500905774
Labeler code
50090
Product ID
50090-5774_20d45a89-a93e-4560-9091-fe1747b2b7e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208621
Marketing category
ANDA
Marketing start
2018-08-20
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
5 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
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
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5774-02023-01-30C16284748780-1f386c649-d52f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998
50090-5774-12023-01-30C16284748780-1f386c649-d52f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5774-0montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE302
50090-5774-1montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5774MONTELUKAST SODIUM TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20211010_b584f59e-2137-4786-8365-1e41e4c3c7db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSNb584f59e-2137-4786-8365-1e41e4c3c7db2
242438montelukast 5 MG Chewable TabletSCDb584f59e-2137-4786-8365-1e41e4c3c7db2
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYb584f59e-2137-4786-8365-1e41e4c3c7db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5774-05009057740030 TABLET, CHEWABLE in 1 BOTTLE (50090-5774-0) 2021-10-070000-00-00NoNoCurrent
50090-5774-15009057740190 TABLET, CHEWABLE in 1 BOTTLE (50090-5774-1) 2021-10-070000-00-00NoNoCurrent