FDA.reportPublic FDA data

MONTELUKAST SODIUM

Product NDC
63187-692
11-digit product format
631870692
Labeler code
63187
Product ID
63187-692_51ba5811-a7f6-4c07-abde-873a75ba5554
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203432
Marketing category
ANDA
Marketing start
2015-11-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MONTELUKAST SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-692-30MONTELUKAST SODIUM30 in 1 BOTTLETABLET, COATED303
63187-692-60MONTELUKAST SODIUM60 in 1 BOTTLETABLET, COATED603
63187-692-90MONTELUKAST SODIUM90 in 1 BOTTLETABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-692MONTELUKAST SODIUM TABLET, COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210112_901385e5-7384-4c28-a36a-7dd84c36f5fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN901385e5-7384-4c28-a36a-7dd84c36f5fd3
200224montelukast 10 MG Oral TabletSCD901385e5-7384-4c28-a36a-7dd84c36f5fd3
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY901385e5-7384-4c28-a36a-7dd84c36f5fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-692-306318706923030 TABLET, COATED in 1 BOTTLE (63187-692-30) 2016-04-010000-00-00NoNoCurrent
63187-692-606318706926060 TABLET, COATED in 1 BOTTLE (63187-692-60) 2016-04-010000-00-00NoNoCurrent
63187-692-906318706929090 TABLET, COATED in 1 BOTTLE (63187-692-90) 2016-04-010000-00-00NoNoCurrent