FDA.reportPublic FDA data

MONTELUKAST

Product NDC
63187-626
11-digit product format
631870626
Labeler code
63187
Product ID
63187-626_b54fe609-9c8c-4ca3-bd5c-8f3ab197f969
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203037
Marketing category
ANDA
Marketing start
2014-12-01
Substance
MONTELUKAST SODIUM
Active strength
5 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui242438

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
63187-626-30MONTELUKAST30 in 1 BOTTLETABLET, CHEWABLE303
63187-626-60MONTELUKAST60 in 1 BOTTLETABLET, CHEWABLE603
63187-626-90MONTELUKAST90 in 1 BOTTLETABLET, CHEWABLE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-626MONTELUKAST TABLET, CHEWABLE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191121_9705627c-283e-4743-b261-cfeb88d96e9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSN9705627c-283e-4743-b261-cfeb88d96e9b3
242438montelukast 5 MG Chewable TabletSCD9705627c-283e-4743-b261-cfeb88d96e9b3
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY9705627c-283e-4743-b261-cfeb88d96e9b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-626-306318706263030 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30) 2018-12-010000-00-00NoNoCurrent
63187-626-606318706266060 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60) 2018-12-010000-00-00NoNoCurrent
63187-626-906318706269090 TABLET, CHEWABLE in 1 BOTTLE (63187-626-90) 2018-12-010000-00-00NoNoCurrent