FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
65862-574
11-digit product format
658620574
Labeler code
65862
Product ID
65862-574_035c2d56-5707-4d1e-96b8-7c9c2e848bb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA202468
Marketing category
ANDA
Marketing start
2012-08-03
Substance
MONTELUKAST SODIUM
Active strength
10 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 SODIUM10 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
65862-574-10Montelukast Sodium10 in 1 CARTONTABLET, FILM COATED1021
65862-574-10Montelukast Sodium10 in 1 BLISTER PACKTABLET, FILM COATED1021
65862-574-19Montelukast Sodium10000 in 1 BOTTLETABLET, FILM COATED1000021
65862-574-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED3021
65862-574-90Montelukast Sodium90 in 1 BOTTLETABLET, FILM COATED9021
65862-574-10Montelukast Sodium10 in 1 CARTONTABLET, FILM COATED106
65862-574-10Montelukast Sodium10 in 1 BLISTER PACKTABLET, FILM COATED106
65862-574-19Montelukast Sodium10000 in 1 BOTTLETABLET, FILM COATED100006
65862-574-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED306
65862-574-90Montelukast Sodium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-574MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]21Current NDC, Legacy NDC, 5 package rows20240403_ba42b0a9-83f1-4283-a853-f99cdd0761b9.zip
65862-574MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 5 package rows20141231_7636a692-558f-4649-86d9-b6699c3eeca1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN6ffff72c-8784-477b-8722-5434a19881a024
200224montelukast 10 MG Oral TabletSCD6ffff72c-8784-477b-8722-5434a19881a024
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY6ffff72c-8784-477b-8722-5434a19881a024
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
200224montelukast sodium 10 MG Oral TabletPSN7636a692-558f-4649-86d9-b6699c3eeca16
200224montelukast 10 MG Oral TabletSCD7636a692-558f-4649-86d9-b6699c3eeca16
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY7636a692-558f-4649-86d9-b6699c3eeca16
200224montelukast sodium 10 MG Oral TabletPSNb83e509b-f6fd-4d11-adef-516999b2701c5
200224montelukast 10 MG Oral TabletSCDb83e509b-f6fd-4d11-adef-516999b2701c5
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYb83e509b-f6fd-4d11-adef-516999b2701c5
200224montelukast sodium 10 MG Oral TabletPSN46b85c12-52bc-4768-a7c8-40b1546e9e0e1
200224montelukast sodium 10 MG Oral TabletPSN461f2aaa-e091-478e-97c1-27a089db8cdc1
200224montelukast 10 MG Oral TabletSCD461f2aaa-e091-478e-97c1-27a089db8cdc1
200224montelukast 10 MG Oral TabletSCD46b85c12-52bc-4768-a7c8-40b1546e9e0e1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY46b85c12-52bc-4768-a7c8-40b1546e9e0e1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY461f2aaa-e091-478e-97c1-27a089db8cdc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-574-106586205741010 BLISTER PACK in 1 CARTON (65862-574-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-08-030000-00-00NoNoCurrent
65862-574-196586205741910000 TABLET, FILM COATED in 1 BOTTLE (65862-574-19) 2012-08-030000-00-00NoNoCurrent
65862-574-306586205743030 TABLET, FILM COATED in 1 BOTTLE (65862-574-30) 2012-08-030000-00-00NoNoCurrent
65862-574-35658620574353500 TABLET, FILM COATED in 1 BAG (65862-574-35)03-AUG-12Current
65862-574-906586205749090 TABLET, FILM COATED in 1 BOTTLE (65862-574-90) 2012-08-030000-00-00NoNoCurrent