FDA.reportPublic FDA data

montelukast sodium

Product NDC
50090-2921
11-digit product format
500902921
Labeler code
50090
Product ID
50090-2921_2080cbb8-f8f8-4ad7-ac99-74d59ba79bd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204093
Marketing category
ANDA
Marketing start
2015-05-27
Substance
MONTELUKAST
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
montelukast sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMHM278SD3E
Rxcui311759

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2921-02023-02-07C16284748780-1f386c64a-45ee-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998
50090-2921-12023-02-07C16284748780-1f386c64a-45ee-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998
50090-2921-02023-01-30C16284748780-1f386c64a-45ee-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998
50090-2921-12023-01-30C16284748780-1f386c64a-45ee-0266-e053-dadaa90a7c1aHIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. MONTELUKAST Sodium Chewable Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2921-0montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE3017
50090-2921-1montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2921-0EA - Each50090-29215b8f2e5d-c321-4eb0-8e74-03a763f63b3b12021-08-05
50090-2921-1EA - Each50090-292113fa1e5b-d3d2-45f5-9a10-58b44c3c792e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2921MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20240530_25b2049d-3a93-4ac3-8de6-14f5d7ce0315.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast 4 MG Chewable TabletSCD25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY25b2049d-3a93-4ac3-8de6-14f5d7ce031517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2921-05009029210030 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-0) 2017-03-150000-00-00NoNoCurrent
50090-2921-15009029210190 TABLET, CHEWABLE in 1 BOTTLE (50090-2921-1) 2018-10-050000-00-00NoNoCurrent