FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
71610-129
11-digit product format
716100129
Labeler code
71610
Product ID
71610-129_797baf6f-f318-4380-abac-4218838ce3bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA202468
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
2019-12-31
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
71610-129-092020-01-31C16284748780-19d75b9d0-9076-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998
71610-129-302020-01-31C16284748780-19d75b9d0-9076-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM chewable tablets, for oral use MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-129-09Montelukast Sodium9000 in 1 BOTTLETABLET, FILM COATED90001
71610-129-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-129-09EA - Each71610-1299c58eb17-132f-4561-9fc1-d298907aa2f312018-11-06
71610-129-30EA - Each71610-1299df5a96f-fb2e-49de-b058-c92bf69d507512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-129MONTELUKAST SODIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20180912_46b85c12-52bc-4768-a7c8-40b1546e9e0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN46b85c12-52bc-4768-a7c8-40b1546e9e0e1
200224montelukast 10 MG Oral TabletSCD46b85c12-52bc-4768-a7c8-40b1546e9e0e1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY46b85c12-52bc-4768-a7c8-40b1546e9e0e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71610-129-09716100129099000 in 1 BOTTLEHistorical
71610-129-307161001293030 in 1 BOTTLEHistorical