FDA.reportPublic FDA data

Montelukast sodium

Product NDC
33342-111
11-digit product format
333420111
Labeler code
33342
Product ID
33342-111_a12af8c6-41af-4850-b725-4f8226b35b67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203582
Marketing category
ANDA
Marketing start
2015-03-13
Substance
MONTELUKAST
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
MONTELUKAST5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMHM278SD3E
Rxcui242438, 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
33342-111-07Montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE308
33342-111-10Montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE908
33342-111-12Montelukast sodium100 in 1 BLISTER PACKTABLET, CHEWABLE1008
33342-111-15Montelukast sodium500 in 1 BOTTLETABLET, CHEWABLE5008
33342-111-39Montelukast sodium90 in 1 BLISTER PACKTABLET, CHEWABLE908
33342-111-44Montelukast sodium1000 in 1 BOTTLETABLET, CHEWABLE10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-111MONTELUKAST SODIUM TABLET, CHEWABLE [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 6 package rows20230917_ce512844-5220-4661-809f-56d088699c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSNce512844-5220-4661-809f-56d088699c9c8
242438montelukast sodium 5 MG Chewable TabletPSNce512844-5220-4661-809f-56d088699c9c8
311759montelukast 4 MG Chewable TabletSCDce512844-5220-4661-809f-56d088699c9c8
242438montelukast 5 MG Chewable TabletSCDce512844-5220-4661-809f-56d088699c9c8
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYce512844-5220-4661-809f-56d088699c9c8
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYce512844-5220-4661-809f-56d088699c9c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-111-073334201110730 TABLET, CHEWABLE in 1 BOTTLE (33342-111-07) 2015-03-130000-00-00NoNoCurrent
33342-111-103334201111090 TABLET, CHEWABLE in 1 BOTTLE (33342-111-10) 2015-03-130000-00-00NoNoCurrent
33342-111-1233342011112100 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-12) 2015-03-130000-00-00NoNoCurrent
33342-111-1533342011115500 TABLET, CHEWABLE in 1 BOTTLE (33342-111-15) 2015-03-130000-00-00NoNoCurrent
33342-111-393334201113990 TABLET, CHEWABLE in 1 BLISTER PACK (33342-111-39) 2015-03-130000-00-00NoNoCurrent
33342-111-44333420111441000 TABLET, CHEWABLE in 1 BOTTLE (33342-111-44) 2015-09-250000-00-00NoNoCurrent