FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
50268-573
11-digit product format
502680573
Labeler code
50268
Product ID
50268-573_42525d29-7cfc-ee26-e063-6294a90a9f7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
AvPAK
Application
ANDA200405
Marketing category
ANDA
Marketing start
2014-11-12
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
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
50268-573-11Montelukast Sodium1 in 1 BLISTER PACKTABLET, CHEWABLE18
50268-573-15Montelukast Sodium50 in 1 BOXTABLET, CHEWABLE508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-573-11EA - Each50268-573090182a7-c708-444b-8948-012ccb7b820912015-02-02
50268-573-15EA - Each50268-573eaf77fbd-8c9d-4184-b4c4-3bdc6be770de12015-02-02

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 [AVPAK]2
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
HypromellosesINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-573MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AVPAK]7Current NDC, Legacy NDC, 2 package rows20221202_2f90a573-27fd-cc16-f3d1-8c4d630224a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN2f90a573-27fd-cc16-f3d1-8c4d630224a08
311759montelukast sodium 4 MG Chewable TabletPSN2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast sodium 5 MG Chewable TabletPSN2f90a573-27fd-cc16-f3d1-8c4d630224a08
200224montelukast 10 MG Oral TabletSCD2f90a573-27fd-cc16-f3d1-8c4d630224a08
311759montelukast 4 MG Chewable TabletSCD2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast 5 MG Chewable TabletSCD2f90a573-27fd-cc16-f3d1-8c4d630224a08
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2f90a573-27fd-cc16-f3d1-8c4d630224a08
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY2f90a573-27fd-cc16-f3d1-8c4d630224a08
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY2f90a573-27fd-cc16-f3d1-8c4d630224a08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-573-11502680573111 in 1 BLISTER PACKHistorical
50268-573-155026805731550 BLISTER PACK in 1 BOX (50268-573-15) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (50268-573-11) 50 blister pack2014-11-120000-00-00NoNoCurrent