FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
53002-1441
11-digit product format
530021441
Labeler code
53002
Product ID
53002-1441_d19aa2cb-36a2-4547-a340-0c4a9421d44c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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
53002-1441-32025-01-30C16284748780-19d75b9d0-f3d0-f424-e053-dadaa90a57ceThese 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
53002-1441-32023-06-07C16284748780-19d75b9d0-f3d0-f424-e053-dadaa90a57ceThese 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
53002-1441-32023-01-30C16284748780-19d75b9d0-f3d0-f424-e053-dadaa90a57ceThese 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
53002-1441-32020-12-16C16284748780-19d75b9d0-f3d0-f424-e053-dadaa90a57ceThese 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
53002-1441-32020-01-31C16284748780-19d75b9d0-f3d0-f424-e053-dadaa90a57ceThese 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
53002-1441-3Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1441MONTELUKAST SODIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_fdc5e630-3a01-4db6-8107-0e220dca2ba1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNfdc5e630-3a01-4db6-8107-0e220dca2ba15
200224montelukast 10 MG Oral TabletSCDfdc5e630-3a01-4db6-8107-0e220dca2ba15
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYfdc5e630-3a01-4db6-8107-0e220dca2ba15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1441-35300214410330 TABLET, FILM COATED in 1 BOTTLE (53002-1441-3) 2017-09-010000-00-00NoNoCurrent