FDA.reportPublic FDA data

montelukast sodium

Product NDC
31722-727
11-digit product format
317220727
Labeler code
31722
Product ID
31722-727_c503ea71-c663-3cfc-e053-2a95a90a9aaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204093
Marketing category
ANDA
Marketing start
2015-05-27
Substance
MONTELUKAST
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
MONTELUKAST4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMHM278SD3E
Rxcui242438, 311759

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
31722-727-01montelukast sodium100 in 1 BOTTLETABLET, CHEWABLE1006
31722-727-10montelukast sodium1000 in 1 BOTTLETABLET, CHEWABLE10006
31722-727-30montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE306
31722-727-31montelukast sodium10 in 1 BLISTER PACKTABLET, CHEWABLE106
31722-727-32montelukast sodium100 in 1 CARTONTABLET, CHEWABLE1006
31722-727-90montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-727-30EA - Each31722-727b092a5c8-71ca-4396-953e-8f02e161d02f12015-11-12
31722-727-90EA - Each31722-727ff90b883-4dfd-4e66-ad8f-9584ede8895e12017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKASTACTIVE INGREDIENTMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
CHERRYINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-727MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 6 package rows20210618_23964723-2df8-4d0a-a53d-8538469672f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast 4 MG Chewable TabletSCD25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY25b2049d-3a93-4ac3-8de6-14f5d7ce031517
311759montelukast sodium 4 MG Chewable TabletPSN23964723-2df8-4d0a-a53d-8538469672f16
242438montelukast sodium 5 MG Chewable TabletPSN23964723-2df8-4d0a-a53d-8538469672f16
311759montelukast 4 MG Chewable TabletSCD23964723-2df8-4d0a-a53d-8538469672f16
242438montelukast 5 MG Chewable TabletSCD23964723-2df8-4d0a-a53d-8538469672f16
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY23964723-2df8-4d0a-a53d-8538469672f16
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY23964723-2df8-4d0a-a53d-8538469672f16
311759montelukast sodium 4 MG Chewable TabletPSN3ff4100f-11e3-4d6a-ab88-83bd605a18185
311759montelukast 4 MG Chewable TabletSCD3ff4100f-11e3-4d6a-ab88-83bd605a18185
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY3ff4100f-11e3-4d6a-ab88-83bd605a18185
311759montelukast sodium 4 MG Chewable TabletPSN04b3faff-1ea1-4d2a-aa31-9d6e742e17591
311759montelukast 4 MG Chewable TabletSCD04b3faff-1ea1-4d2a-aa31-9d6e742e17591
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY04b3faff-1ea1-4d2a-aa31-9d6e742e17591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-727-0131722072701100 TABLET, CHEWABLE in 1 BOTTLE (31722-727-01) 2015-05-270000-00-00NoNoCurrent
31722-727-10317220727101000 TABLET, CHEWABLE in 1 BOTTLE (31722-727-10) 2015-05-270000-00-00NoNoCurrent
31722-727-303172207273030 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30) 2015-05-270000-00-00NoNoCurrent
31722-727-313172207273110 TABLET, CHEWABLE in 1 BLISTER PACK (31722-727-31) 2015-05-270000-00-00NoNoCurrent
31722-727-3231722072732100 TABLET, CHEWABLE in 1 CARTON (31722-727-32) 2015-05-270000-00-00NoNoCurrent
31722-727-903172207279090 TABLET, CHEWABLE in 1 BOTTLE (31722-727-90) 2015-05-270000-00-00NoNoCurrent