Montelukast Sodium

Product NDC
68151-3494
11-digit product format
681513494
Labeler code
68151
Product ID
68151-3494_6989dc60-abad-4644-bfd0-38a9afdf1a86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
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
E
Listing certified through
2018-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3494-2Montelukast Sodium1 in 1 BOTTLETABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3494MONTELUKAST SODIUM TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20170706_d40cc9a6-d4c5-43e2-902c-46bf7158734a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNd40cc9a6-d4c5-43e2-902c-46bf7158734a3
200224montelukast 10 MG Oral TabletSCDd40cc9a6-d4c5-43e2-902c-46bf7158734a3
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYd40cc9a6-d4c5-43e2-902c-46bf7158734a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3494-2681513494021 in 1 BOTTLEHistorical