FDA.reportPublic FDA data

MONTELUKAST SODIUM

Product NDC
63629-8235
11-digit product format
636298235
Labeler code
63629
Product ID
63629-8235_d16b5541-7366-4338-9ca4-06ce26be9619
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203328
Marketing category
ANDA
Marketing start
2015-08-13
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
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
63629-8235-12024-01-30C16284748780-11030e365-3646-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM oral granules Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8235-1MONTELUKAST SODIUM30 in 1 BOTTLETABLET, CHEWABLE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8235MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [BRYANT RANCH PREPACK]2Legacy NDC, 1 package rows20220120_d16b5541-7366-4338-9ca4-06ce26be9619.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSNd16b5541-7366-4338-9ca4-06ce26be96192
242438montelukast 5 MG Chewable TabletSCDd16b5541-7366-4338-9ca4-06ce26be96192
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYd16b5541-7366-4338-9ca4-06ce26be96192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8235-16362982350130 TABLET, CHEWABLE in 1 BOTTLE (63629-8235-1) 2019-09-060000-00-00NoNoCurrent