FDA.reportPublic FDA data

montelukast sodium

Product NDC
50090-2480
11-digit product format
500902480
Labeler code
50090
Product ID
50090-2480_3bc1370b-3a65-4681-8de5-2fa41c269ca2
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
50090-2480-02023-01-30C16284748780-1f386c649-dd33-0266-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
50090-2480-12023-01-30C16284748780-1f386c649-dd33-0266-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
50090-2480-0montelukast sodium30 in 1 BOTTLETABLET, FILM COATED3013
50090-2480-1montelukast sodium90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2480-0EA - Each50090-2480991837ac-d156-4bb9-8a45-831abb7106a612019-03-12
50090-2480-1EA - Each50090-2480453cae86-4cf3-404d-979b-a72229df910812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2480MONTELUKAST SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Legacy NDC, 2 package rows20210617_5b500ba9-8a81-4034-beee-86846c561fbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN5b500ba9-8a81-4034-beee-86846c561fbe13
200224montelukast 10 MG Oral TabletSCD5b500ba9-8a81-4034-beee-86846c561fbe13
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY5b500ba9-8a81-4034-beee-86846c561fbe13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2480-05009024800030 TABLET, FILM COATED in 1 BOTTLE (50090-2480-0) 2016-10-050000-00-00NoNoCurrent
50090-2480-15009024800190 TABLET, FILM COATED in 1 BOTTLE (50090-2480-1) 2016-10-260000-00-00NoNoCurrent