FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
71610-051
11-digit product format
716100051
Labeler code
71610
Product ID
71610-051_4bfc30d1-965f-4757-b858-4cf8e1a01157
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091576
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
71610-051-302020-01-31C16284748780-19d75b9d0-7e28-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. 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
71610-051-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-051-30EA - Each71610-0512eb541a7-a25d-4a00-a7a3-b46528a88bba12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-051MONTELUKAST SODIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20180428_8f37955b-3a00-40d5-bf54-d0be1265510c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN8f37955b-3a00-40d5-bf54-d0be1265510c1
200224montelukast 10 MG Oral TabletSCD8f37955b-3a00-40d5-bf54-d0be1265510c1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY8f37955b-3a00-40d5-bf54-d0be1265510c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71610-051-307161000513030 in 1 BOTTLEHistorical