FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
63187-550
11-digit product format
631870550
Labeler code
63187
Product ID
63187-550_37777419-2952-40eb-a2a1-c5f50b20b1dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090984
Marketing category
ANDA
Marketing start
2012-08-03
Substance
MONTELUKAST SODIUM
Active strength
4 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 SODIUM4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui311759

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-550-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE304
63187-550-60Montelukast Sodium60 in 1 BOTTLETABLET, CHEWABLE604
63187-550-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-550MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20231030_07d5fbea-b183-41c9-a20f-30da1f44ab1b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN07d5fbea-b183-41c9-a20f-30da1f44ab1b4
311759montelukast 4 MG Chewable TabletSCD07d5fbea-b183-41c9-a20f-30da1f44ab1b4
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY07d5fbea-b183-41c9-a20f-30da1f44ab1b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-550-306318705503030 TABLET, CHEWABLE in 1 BOTTLE (63187-550-30) 2018-12-010000-00-00NoNoCurrent
63187-550-606318705506060 TABLET, CHEWABLE in 1 BOTTLE (63187-550-60) 2018-12-010000-00-00NoNoCurrent
63187-550-906318705509090 TABLET, CHEWABLE in 1 BOTTLE (63187-550-90) 2018-12-010000-00-00NoNoCurrent