FDA.reportPublic FDA data

MONTELUKAST SODIUM

Product NDC
31722-726
11-digit product format
317220726
Labeler code
31722
Product ID
31722-726_30387eb8-222d-146e-e063-6294a90a12a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA202843
Marketing category
ANDA
Marketing start
2014-09-10
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

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
31722-726-01MONTELUKAST SODIUM100 in 1 BOTTLETABLET, FILM COATED1008
31722-726-10MONTELUKAST SODIUM1000 in 1 BOTTLETABLET, FILM COATED10008
31722-726-30MONTELUKAST SODIUM30 in 1 BOTTLETABLET, FILM COATED308
31722-726-31MONTELUKAST SODIUM10 in 1 BLISTER PACKTABLET, FILM COATED108
31722-726-32MONTELUKAST SODIUM10 in 1 CARTONTABLET, FILM COATED108
31722-726-90MONTELUKAST SODIUM90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-726-10EA - Each31722-7267531f09c-3894-4a0e-86c1-5c78c93948f912015-01-05
31722-726-30EA - Each31722-726e5fa93a5-d4f9-43d3-ae86-1c4b5e9a43e012015-01-05
31722-726-90EA - Each31722-72684cff599-f2d7-4281-b503-0dd8daf13b8612015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-726MONTELUKAST (MONTELUKAST) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 6 package rows20210622_97a682c2-7e00-4d07-a5ac-4436c977f842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN6b26218d-52a6-4109-90e4-412a17d14fcf104
200224montelukast 10 MG Oral TabletSCD6b26218d-52a6-4109-90e4-412a17d14fcf104
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY6b26218d-52a6-4109-90e4-412a17d14fcf104
200224montelukast sodium 10 MG Oral TabletPSNecaa9b4b-5941-4af5-930c-35e9f3b2b4ba9
200224montelukast 10 MG Oral TabletSCDecaa9b4b-5941-4af5-930c-35e9f3b2b4ba9
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYecaa9b4b-5941-4af5-930c-35e9f3b2b4ba9
200224montelukast sodium 10 MG Oral TabletPSN97a682c2-7e00-4d07-a5ac-4436c977f8428
200224montelukast 10 MG Oral TabletSCD97a682c2-7e00-4d07-a5ac-4436c977f8428
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY97a682c2-7e00-4d07-a5ac-4436c977f8428
200224montelukast sodium 10 MG Oral TabletPSN94642db1-5c75-44c4-92b4-8385b486df825
200224montelukast sodium 10 MG Oral TabletPSNa4dc63cf-8145-42f4-9437-93b414d2aed45
200224montelukast 10 MG Oral TabletSCD94642db1-5c75-44c4-92b4-8385b486df825
200224montelukast 10 MG Oral TabletSCDa4dc63cf-8145-42f4-9437-93b414d2aed45
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY94642db1-5c75-44c4-92b4-8385b486df825
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYa4dc63cf-8145-42f4-9437-93b414d2aed45
200224montelukast sodium 10 MG Oral TabletPSNd7870c45-5a8b-8369-e053-2a95a90ae1f34
200224montelukast 10 MG Oral TabletSCDd7870c45-5a8b-8369-e053-2a95a90ae1f34
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYd7870c45-5a8b-8369-e053-2a95a90ae1f34
200224montelukast sodium 10 MG Oral TabletPSNf3bdf2a3-d661-5128-e053-2995a90a46613
200224montelukast sodium 10 MG Oral TabletPSN6741830f-5d90-4066-bc3b-065059bc150d3
200224montelukast 10 MG Oral TabletSCD6741830f-5d90-4066-bc3b-065059bc150d3
200224montelukast 10 MG Oral TabletSCDf3bdf2a3-d661-5128-e053-2995a90a46613
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY6741830f-5d90-4066-bc3b-065059bc150d3
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYf3bdf2a3-d661-5128-e053-2995a90a46613
200224montelukast sodium 10 MG Oral TabletPSNcbe40638-2489-5812-e053-2995a90a236c2
200224montelukast sodium 10 MG Oral TabletPSN0f4506f7-0ffb-4844-8520-97f372fa8b4a2
200224montelukast 10 MG Oral TabletSCDcbe40638-2489-5812-e053-2995a90a236c2
200224montelukast 10 MG Oral TabletSCD0f4506f7-0ffb-4844-8520-97f372fa8b4a2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYcbe40638-2489-5812-e053-2995a90a236c2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY0f4506f7-0ffb-4844-8520-97f372fa8b4a2
200224montelukast sodium 10 MG Oral TabletPSNda9821f1-536a-416b-9594-210bde0cefaf1
200224montelukast 10 MG Oral TabletSCDda9821f1-536a-416b-9594-210bde0cefaf1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYda9821f1-536a-416b-9594-210bde0cefaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-726-0131722072601100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01) 2014-09-100000-00-00NoNoCurrent
31722-726-10317220726101000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10) 2014-09-100000-00-00NoNoCurrent
31722-726-303172207263030 TABLET, FILM COATED in 1 BOTTLE (31722-726-30) 2014-09-100000-00-00NoNoCurrent
31722-726-313172207263110 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) 2014-09-100000-00-00NoNoCurrent
31722-726-323172207263210 BLISTER PACK in 1 CARTON (31722-726-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) 10 blister pack2014-09-100000-00-00NoNoCurrent
31722-726-903172207269090 TABLET, FILM COATED in 1 BOTTLE (31722-726-90) 2014-09-100000-00-00NoNoCurrent