FDA.reportPublic FDA data

MONTELUKAST

Product NDC
0143-9651
11-digit product format
001439651
Labeler code
0143
Product ID
0143-9651_88edb668-e5cc-4bdc-8cb0-622ebed87063
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
West ward Pharmaceutical Corp
Application
ANDA203037
Marketing category
ANDA
Marketing start
2014-12-01
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
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
0143-9651-092020-01-31C16284748780-19d75b9d0-21fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998
0143-9651-102020-01-31C16284748780-19d75b9d0-21fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 1998
0143-9651-302020-01-31C16284748780-19d75b9d0-21fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. 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
0143-9651-09MONTELUKAST90 in 1 BOTTLETABLET, CHEWABLE903
0143-9651-10MONTELUKAST1000 in 1 BOTTLETABLET, CHEWABLE10003
0143-9651-30MONTELUKAST30 in 1 BOTTLETABLET, CHEWABLE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9651-09EA - Each0143-9651a1a6473a-bcd4-48c0-8f79-b0a01f066d8412015-07-20
0143-9651-10EA - Each0143-965156667bcb-9c26-4c70-b601-a85dfe72ffdc12015-07-20
0143-9651-30EA - Each0143-9651ca2072ca-5bae-49b6-b376-1f3e7b63602512015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
CHERRYINACTIVE INGREDIENTBUC5I9595WMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9651MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [WEST WARD PHARMACEUTICAL CORP]3Legacy NDC, 3 package rows20151030_43b80e54-bd48-46f0-835e-b055e797a8c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN43b80e54-bd48-46f0-835e-b055e797a8c03
311759montelukast sodium 4 MG Chewable TabletPSN43b80e54-bd48-46f0-835e-b055e797a8c03
242438montelukast sodium 5 MG Chewable TabletPSN43b80e54-bd48-46f0-835e-b055e797a8c03
200224montelukast 10 MG Oral TabletSCD43b80e54-bd48-46f0-835e-b055e797a8c03
311759montelukast 4 MG Chewable TabletSCD43b80e54-bd48-46f0-835e-b055e797a8c03
242438montelukast 5 MG Chewable TabletSCD43b80e54-bd48-46f0-835e-b055e797a8c03
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY43b80e54-bd48-46f0-835e-b055e797a8c03
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY43b80e54-bd48-46f0-835e-b055e797a8c03
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY43b80e54-bd48-46f0-835e-b055e797a8c03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0143-9651-090014396510990 in 1 BOTTLEHistorical
0143-9651-10001439651101000 in 1 BOTTLEHistorical
0143-9651-300014396513030 in 1 BOTTLEHistorical