FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
42291-623
11-digit product format
422910623
Labeler code
42291
Product ID
42291-623_4617d4b7-780e-f9ce-e063-6294a90aa00b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
AvKARE
Application
ANDA200405
Marketing category
ANDA
Marketing start
2013-01-04
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224, 242438, 311759

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
42291-623-10Montelukast Sodium1000 in 1 BOTTLETABLET, CHEWABLE100022
42291-623-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3022
42291-623-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-623MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AVKARE]20Current NDC, Legacy NDC, 3 package rows20250112_ed2caffa-a75c-1c27-ae30-2d8280eaea7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNed2caffa-a75c-1c27-ae30-2d8280eaea7d22
311759montelukast sodium 4 MG Chewable TabletPSNed2caffa-a75c-1c27-ae30-2d8280eaea7d22
242438montelukast sodium 5 MG Chewable TabletPSNed2caffa-a75c-1c27-ae30-2d8280eaea7d22
200224montelukast 10 MG Oral TabletSCDed2caffa-a75c-1c27-ae30-2d8280eaea7d22
311759montelukast 4 MG Chewable TabletSCDed2caffa-a75c-1c27-ae30-2d8280eaea7d22
242438montelukast 5 MG Chewable TabletSCDed2caffa-a75c-1c27-ae30-2d8280eaea7d22
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYed2caffa-a75c-1c27-ae30-2d8280eaea7d22
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYed2caffa-a75c-1c27-ae30-2d8280eaea7d22
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYed2caffa-a75c-1c27-ae30-2d8280eaea7d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-623-10422910623101000 TABLET, CHEWABLE in 1 BOTTLE (42291-623-10) 2016-08-040000-00-00NoNoCurrent
42291-623-304229106233030 TABLET, CHEWABLE in 1 BOTTLE (42291-623-30) 2013-01-040000-00-00NoNoCurrent
42291-623-904229106239090 TABLET, CHEWABLE in 1 BOTTLE (42291-623-90) 2013-01-040000-00-00NoNoCurrent