FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
63629-8106
11-digit product format
636298106
Labeler code
63629
Product ID
63629-8106_b8b86f2b-1fe3-4a58-9bf4-e826166609c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202717
Marketing category
ANDA
Marketing start
2013-04-11
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
63629-8106-12024-01-30C16284748780-11030e365-1c7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998
63629-8106-22024-01-30C16284748780-11030e365-1c7a-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8106-1Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED302
63629-8106-2Montelukast Sodium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8106MONTELUKAST SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]2Legacy NDC, 2 package rows20220119_b8b86f2b-1fe3-4a58-9bf4-e826166609c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNb8b86f2b-1fe3-4a58-9bf4-e826166609c32
200224montelukast 10 MG Oral TabletSCDb8b86f2b-1fe3-4a58-9bf4-e826166609c32
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYb8b86f2b-1fe3-4a58-9bf4-e826166609c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8106-16362981060130 TABLET, FILM COATED in 1 BOTTLE (63629-8106-1) 2019-07-250000-00-00NoNoCurrent
63629-8106-26362981060290 TABLET, FILM COATED in 1 BOTTLE (63629-8106-2) 2019-07-250000-00-00NoNoCurrent