FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
42291-622
11-digit product format
422910622
Labeler code
42291
Product ID
42291-622_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
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
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
42291-622-10Montelukast Sodium1000 in 1 BOTTLETABLET, CHEWABLE100022
42291-622-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3022
42291-622-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-622-10EA - Each42291-622fe047f4f-17c0-435d-88f9-b59ebed5ee1212016-09-02
42291-622-30EA - Each42291-622e9cfc457-2824-439d-84fd-61c8ccaa61a312013-02-13
42291-622-90EA - Each42291-62210cf0db1-25f7-4d3f-96f5-3b32aa8fb8fb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
MontelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
HypromellosesINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
mannitolINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
polyvinyl alcoholINACTIVE INGREDIENT532B59J990MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
sodium stearyl fumarateINACTIVE INGREDIENT7CV7WJK4UIMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
talcINACTIVE INGREDIENT7SEV7J4R1UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-622MONTELUKAST 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
42291-622-10422910622101000 TABLET, CHEWABLE in 1 BOTTLE (42291-622-10) 2016-08-040000-00-00NoNoCurrent
42291-622-304229106223030 TABLET, CHEWABLE in 1 BOTTLE (42291-622-30) 2013-01-040000-00-00NoNoCurrent
42291-622-904229106229090 TABLET, CHEWABLE in 1 BOTTLE (42291-622-90) 2013-01-040000-00-00NoNoCurrent