FDA.reportPublic FDA data

montelukast sodium

Product NDC
50090-4919
11-digit product format
500904919
Labeler code
50090
Product ID
50090-4919_839c07d8-1bf5-44e1-9b5b-2b0939cc1f82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204290
Marketing category
ANDA
Marketing start
2016-01-01
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
10 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
50090-4919-02023-01-30C16284748780-1f386c64a-4a09-0266-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
50090-4919-0montelukast sodium90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4919MONTELUKAST SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210615_9b560283-cfa3-4289-b4cc-3f1237e668c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN9b560283-cfa3-4289-b4cc-3f1237e668c35
200224montelukast 10 MG Oral TabletSCD9b560283-cfa3-4289-b4cc-3f1237e668c35
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY9b560283-cfa3-4289-b4cc-3f1237e668c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4919-05009049190090 TABLET, FILM COATED in 1 BOTTLE (50090-4919-0) 2020-02-180000-00-00NoNoCurrent