FDA.reportPublic FDA data

Montelukast

Product NDC
63629-4886
11-digit product format
636294886
Labeler code
63629
Product ID
63629-4886_e67c211a-cee7-41e8-9a2a-32d7363ef2a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200889
Marketing category
ANDA
Marketing start
2012-08-03
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
10 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-4886-12024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-22024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-32024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-42024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-52024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-62024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-72024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-82024-01-30C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-12022-02-16C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-22022-02-16C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-32022-02-16C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-42022-02-16C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-52022-02-16C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-62022-02-16C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-12019-11-27C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-22019-11-27C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-32019-11-27C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-42019-11-27C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-52019-11-27C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998
63629-4886-62019-11-27C16284748780-19855e2a2-3309-60a7-e053-dbdaa90a05bdThese 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 MONTELUKAST sodium chewable tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4886-1Montelukast30 in 1 BOTTLETABLET, FILM COATED301002
63629-4886-2Montelukast4 in 1 BOTTLETABLET, FILM COATED41002
63629-4886-3Montelukast7 in 1 BOTTLETABLET, FILM COATED71002
63629-4886-4Montelukast60 in 1 BOTTLETABLET, FILM COATED601002
63629-4886-5Montelukast10 in 1 BOTTLETABLET, FILM COATED101002
63629-4886-6Montelukast90 in 1 BOTTLETABLET, FILM COATED901002
63629-4886-7Montelukast120 in 1 BOTTLETABLET, FILM COATED1201002
63629-4886-8Montelukast15 in 1 BOTTLETABLET, FILM COATED151002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4886MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1002Legacy NDC, 8 package rows20220217_e67c211a-cee7-41e8-9a2a-32d7363ef2a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNe67c211a-cee7-41e8-9a2a-32d7363ef2a31002
200224montelukast 10 MG Oral TabletSCDe67c211a-cee7-41e8-9a2a-32d7363ef2a31002
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYe67c211a-cee7-41e8-9a2a-32d7363ef2a31002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4886-16362948860130 TABLET, FILM COATED in 1 BOTTLE (63629-4886-1) 2013-01-170000-00-00NoNoCurrent
63629-4886-2636294886024 TABLET, FILM COATED in 1 BOTTLE (63629-4886-2) 2022-02-080000-00-00NoNoCurrent
63629-4886-3636294886037 TABLET, FILM COATED in 1 BOTTLE (63629-4886-3) 2013-02-140000-00-00NoNoCurrent
63629-4886-46362948860460 TABLET, FILM COATED in 1 BOTTLE (63629-4886-4) 2013-07-160000-00-00NoNoCurrent
63629-4886-56362948860510 TABLET, FILM COATED in 1 BOTTLE (63629-4886-5) 2022-02-080000-00-00NoNoCurrent
63629-4886-66362948860690 TABLET, FILM COATED in 1 BOTTLE (63629-4886-6) 2014-01-300000-00-00NoNoCurrent
63629-4886-763629488607120 TABLET, FILM COATED in 1 BOTTLE (63629-4886-7) 2022-02-080000-00-00NoNoCurrent
63629-4886-86362948860815 TABLET, FILM COATED in 1 BOTTLE (63629-4886-8) 2022-02-080000-00-00NoNoCurrent