FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
65862-567
11-digit product format
658620567
Labeler code
65862
Product ID
65862-567_035c2d56-5707-4d1e-96b8-7c9c2e848bb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202096
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
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
65862-567-05Montelukast Sodium500 in 1 BOTTLETABLET, CHEWABLE50021
65862-567-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3021
65862-567-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-567-05EA - Each65862-5672d25b2fb-73ac-4453-9c18-d717a492eda012013-02-13
65862-567-30EA - Each65862-567021c1446-77fd-41d2-abb2-e3ef1ed00b2512013-02-13
65862-567-90EA - Each65862-56736c1dc3d-b931-41df-8f6c-956a12b2202112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CHERRYINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-567MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]21Current NDC, Legacy NDC, 3 package rows20240403_ba42b0a9-83f1-4283-a853-f99cdd0761b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNba42b0a9-83f1-4283-a853-f99cdd0761b921
311759montelukast sodium 4 MG Chewable TabletPSNba42b0a9-83f1-4283-a853-f99cdd0761b921
242438montelukast sodium 5 MG Chewable TabletPSNba42b0a9-83f1-4283-a853-f99cdd0761b921
200224montelukast 10 MG Oral TabletSCDba42b0a9-83f1-4283-a853-f99cdd0761b921
311759montelukast 4 MG Chewable TabletSCDba42b0a9-83f1-4283-a853-f99cdd0761b921
242438montelukast 5 MG Chewable TabletSCDba42b0a9-83f1-4283-a853-f99cdd0761b921
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYba42b0a9-83f1-4283-a853-f99cdd0761b921
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYba42b0a9-83f1-4283-a853-f99cdd0761b921
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYba42b0a9-83f1-4283-a853-f99cdd0761b921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-567-0565862056705500 TABLET, CHEWABLE in 1 BOTTLE (65862-567-05) 2012-08-030000-00-00NoNoCurrent
65862-567-306586205673030 TABLET, CHEWABLE in 1 BOTTLE (65862-567-30) 2012-08-030000-00-00NoNoCurrent
65862-567-906586205679090 TABLET, CHEWABLE in 1 BOTTLE (65862-567-90) 2012-08-030000-00-00NoNoCurrent