FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
68151-4338
11-digit product format
681514338
Labeler code
68151
Product ID
68151-4338_bb23e921-3ab3-4b4d-8301-ce0a1139d08c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA078723
Marketing category
ANDA
Marketing start
2012-08-03
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-4338-52020-01-31C16284748780-19d75b9d0-cfca-f424-e053-dadaa90a57ceThese 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 and chewable tablets for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4338-5Montelukast Sodium1 in 1 PACKAGETABLET, CHEWABLE15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4338MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]5Legacy NDC, 1 package rows20160806_8bc91794-7577-486a-916b-92edadf17cd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN8bc91794-7577-486a-916b-92edadf17cd75
311759montelukast 4 MG Chewable TabletSCD8bc91794-7577-486a-916b-92edadf17cd75
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY8bc91794-7577-486a-916b-92edadf17cd75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4338-5681514338051 in 1 PACKAGEHistorical