FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
60723-004
11-digit product format
607230004
Labeler code
60723
Product ID
60723-004_24533fda-78e7-0586-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.
Application
ANDA205695
Marketing category
ANDA
Marketing start
2015-11-30
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
No
Listing certified through
2019-12-31
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
60723-004-032020-01-31C16284748780-19d75b9d0-26d4-f424-e053-dadaa90a57ceThese 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
60723-004-092020-01-31C16284748780-19d75b9d0-26d4-f424-e053-dadaa90a57ceThese 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
60723-004-502020-01-31C16284748780-19d75b9d0-26d4-f424-e053-dadaa90a57ceThese 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
60723-004-03Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE302
60723-004-09Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE902
60723-004-50Montelukast Sodium500 in 1 BOTTLETABLET, CHEWABLE5002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
HYDROXYPROPYL CELLULOSE (TYPE EL)INACTIVE INGREDIENT8VAB711C5EMONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60723-004MONTELUKAST SODIUM TABLET, CHEWABLE [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]2Legacy NDC, 3 package rows20151130_2e207413-342a-4a7c-b9dd-881e6cd927cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN2e207413-342a-4a7c-b9dd-881e6cd927cf2
242438montelukast sodium 5 MG Chewable TabletPSN2e207413-342a-4a7c-b9dd-881e6cd927cf2
311759montelukast 4 MG Chewable TabletSCD2e207413-342a-4a7c-b9dd-881e6cd927cf2
242438montelukast 5 MG Chewable TabletSCD2e207413-342a-4a7c-b9dd-881e6cd927cf2
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY2e207413-342a-4a7c-b9dd-881e6cd927cf2
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY2e207413-342a-4a7c-b9dd-881e6cd927cf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
60723-004-036072300040330 in 1 BOTTLEHistorical
60723-004-096072300040990 in 1 BOTTLEHistorical
60723-004-5060723000450500 in 1 BOTTLEHistorical