FDA.reportPublic FDA data

SINGULAIR

Product NDC
68258-3032
11-digit product format
682583032
Labeler code
68258
Product ID
68258-3032_6f5962a5-487d-4d7d-a3eb-ec9d1e77caca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Dispensing Solutions Inc.
Application
NDA020830
Marketing category
NDA
Marketing start
2009-10-08
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
68258-3032-32019-10-21C16284748780-1956f9ecf-c5cd-621f-e053-dbdaa90a74adSINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3032-3SINGULAIR30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
MONTELUKASTACTIVE MOIETYMHM278SD3ESINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ASINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3032SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [DISPENSING SOLUTIONS INC.]1Legacy NDC, 1 package rows20100303_10cd5ca5-6f8b-417c-af11-a2054a2dde34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN10cd5ca5-6f8b-417c-af11-a2054a2dde341
242438montelukast sodium 5 MG Chewable TabletPSN10cd5ca5-6f8b-417c-af11-a2054a2dde341
153892Singulair 10 MG Oral TabletPSN10cd5ca5-6f8b-417c-af11-a2054a2dde341
153893Singulair 5 MG Chewable TabletPSN10cd5ca5-6f8b-417c-af11-a2054a2dde341
153892montelukast 10 MG Oral Tablet [Singulair]SBD10cd5ca5-6f8b-417c-af11-a2054a2dde341
153893montelukast 5 MG Chewable Tablet [Singulair]SBD10cd5ca5-6f8b-417c-af11-a2054a2dde341
200224montelukast 10 MG Oral TabletSCD10cd5ca5-6f8b-417c-af11-a2054a2dde341
242438montelukast 5 MG Chewable TabletSCD10cd5ca5-6f8b-417c-af11-a2054a2dde341
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY10cd5ca5-6f8b-417c-af11-a2054a2dde341
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY10cd5ca5-6f8b-417c-af11-a2054a2dde341
153892Singulair 10 MG (montelukast sodium 10.4 MG) Oral TabletSY10cd5ca5-6f8b-417c-af11-a2054a2dde341
153892Singulair 10 MG Oral TabletSY10cd5ca5-6f8b-417c-af11-a2054a2dde341
153893Singulair 5 MG (montelukast sodium 5.2 MG) Chewable TabletSY10cd5ca5-6f8b-417c-af11-a2054a2dde341
153893Singulair 5 MG Chewable TabletSY10cd5ca5-6f8b-417c-af11-a2054a2dde341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-3032-36825830320330 in 1 BOTTLE, PLASTICHistorical