FDA.reportPublic FDA data

Montelukast

Product NDC
33342-102
11-digit product format
333420102
Labeler code
33342
Product ID
33342-102_c0c72c6c-cc59-47ba-9dfb-0af985ae7ea6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203366
Marketing category
ANDA
Marketing start
2014-09-11
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-102-07Montelukast30 in 1 BOTTLETABLET3011
33342-102-10Montelukast90 in 1 BOTTLETABLET9011
33342-102-12Montelukast100 in 1 BLISTER PACKTABLET10011
33342-102-15Montelukast500 in 1 BOTTLETABLET50011
33342-102-39Montelukast90 in 1 BLISTER PACKTABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-102-07EA - Each33342-1024b401352-0e3c-4516-83f0-b6c41198bd4312015-04-03
33342-102-10EA - Each33342-102f3eb11b7-8f95-45a8-82a9-72ded1f882d812015-04-03
33342-102-15EA - Each33342-102d2be2928-e89d-4087-b9e4-3eae55979d2812015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-102MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 5 package rows20230217_e0c5b856-3f70-4ca6-9763-a90673bb82fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNe0c5b856-3f70-4ca6-9763-a90673bb82fb11
200224montelukast 10 MG Oral TabletSCDe0c5b856-3f70-4ca6-9763-a90673bb82fb11
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYe0c5b856-3f70-4ca6-9763-a90673bb82fb11
200224montelukast sodium 10 MG Oral TabletPSN56429f04-97b6-06a9-e054-00144ff88e884
200224montelukast 10 MG Oral TabletSCD56429f04-97b6-06a9-e054-00144ff88e884
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY56429f04-97b6-06a9-e054-00144ff88e884
200224montelukast sodium 10 MG Oral TabletPSN365e1c5c-01b2-bf4e-e063-6394a90a0e431
200224montelukast sodium 10 MG Oral TabletPSN52c650cf-3081-7b2c-e063-6394a90a797f1
200224montelukast 10 MG Oral TabletSCD365e1c5c-01b2-bf4e-e063-6394a90a0e431
200224montelukast 10 MG Oral TabletSCD52c650cf-3081-7b2c-e063-6394a90a797f1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY365e1c5c-01b2-bf4e-e063-6394a90a0e431
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY52c650cf-3081-7b2c-e063-6394a90a797f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-102-073334201020730 TABLET in 1 BOTTLE (33342-102-07) 30 tablet2014-09-110000-00-00NoNoCurrent
33342-102-103334201021090 TABLET in 1 BOTTLE (33342-102-10) 90 tablet2014-09-110000-00-00NoNoCurrent
33342-102-1233342010212100 TABLET in 1 BLISTER PACK (33342-102-12) 100 tablet2014-09-110000-00-00NoNoCurrent
33342-102-1533342010215500 TABLET in 1 BOTTLE (33342-102-15) 500 tablet2014-09-110000-00-00NoNoCurrent
33342-102-393334201023990 TABLET in 1 BLISTER PACK (33342-102-39) 90 tablet2014-09-110000-00-00NoNoCurrent