FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
55111-594
11-digit product format
551110594
Labeler code
55111
Product ID
55111-594_8bc013e8-5324-099d-e603-d78012b126bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA201581
Marketing category
ANDA
Marketing start
2012-08-06
Substance
MONTELUKAST SODIUM
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
MONTELUKAST SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224, 242438, 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
55111-594-05Montelukast Sodium500 in 1 BOTTLETABLET, CHEWABLE50024
55111-594-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3024
55111-594-78Montelukast Sodium10 in 1 CARTONTABLET, CHEWABLE1024
55111-594-79Montelukast Sodium10 in 1 BLISTER PACKTABLET, CHEWABLE1024
55111-594-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-594-30EA - Each55111-594bedc9dfc-b2d7-46ba-8e00-9fdddefd4a9e12013-02-13
55111-594-90EA - Each55111-59456387431-35c9-4852-b7c0-738a9c9a5fc612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
aspartameINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
cherryINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-594MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]24Current NDC, Legacy NDC, 5 package rows20221217_3d4451a9-d73d-b9de-68ec-853bfeff6e4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
311759montelukast sodium 4 MG Chewable TabletPSN3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
242438montelukast sodium 5 MG Chewable TabletPSN3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
200224montelukast 10 MG Oral TabletSCD3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
311759montelukast 4 MG Chewable TabletSCD3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
242438montelukast 5 MG Chewable TabletSCD3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY3d4451a9-d73d-b9de-68ec-853bfeff6e4b24
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY3d4451a9-d73d-b9de-68ec-853bfeff6e4b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-594-0555111059405500 TABLET, CHEWABLE in 1 BOTTLE (55111-594-05) 2012-08-060000-00-00NoNoCurrent
55111-594-305511105943030 TABLET, CHEWABLE in 1 BOTTLE (55111-594-30) 2012-08-060000-00-00NoNoCurrent
55111-594-785511105947810 BLISTER PACK in 1 CARTON (55111-594-78) / 10 TABLET, CHEWABLE in 1 BLISTER PACK (55111-594-79) 10 blister pack2012-08-060000-00-00NoNoCurrent
55111-594-795511105947910 in 1 BLISTER PACKHistorical
55111-594-905511105949090 TABLET, CHEWABLE in 1 BOTTLE (55111-594-90) 2012-08-060000-00-00NoNoCurrent