FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
55111-725
11-digit product format
551110725
Labeler code
55111
Product ID
55111-725_8bc013e8-5324-099d-e603-d78012b126bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA201582
Marketing category
ANDA
Marketing start
2012-08-06
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, 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
55111-725-01Montelukast Sodium100 in 1 BOTTLETABLET, COATED10024
55111-725-10Montelukast Sodium1000 in 1 BOTTLETABLET, COATED100024
55111-725-30Montelukast Sodium30 in 1 BOTTLETABLET, COATED3024
55111-725-78Montelukast Sodium10 in 1 CARTONTABLET, COATED1024
55111-725-79Montelukast Sodium10 in 1 BLISTER PACKTABLET, COATED1024
55111-725-90Montelukast Sodium90 in 1 BOTTLETABLET, COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-725-10EA - Each55111-7251cc2a4bf-bf5c-4e75-8c7a-40d43e0f1c8012013-07-02
55111-725-30EA - Each55111-7255f51677c-d505-4beb-a72e-0a7cbd823b1412013-02-13
55111-725-90EA - Each55111-725293d8d83-c1d9-4a0b-87f5-4afb52f3594412013-02-13
55111-725-94EA - Each55111-7250fc24114-82ae-4864-9f01-4b4bfb9d9be112013-07-02

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
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
aspartameINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
cherryINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-725MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]24Current NDC, Legacy NDC, 6 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
200224montelukast sodium 10 MG Oral TabletPSNfb1b2e4e-a840-447b-b943-ad0b6acc32b59
200224montelukast 10 MG Oral TabletSCDfb1b2e4e-a840-447b-b943-ad0b6acc32b59
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYfb1b2e4e-a840-447b-b943-ad0b6acc32b59
200224montelukast sodium 10 MG Oral TabletPSN26d11120-5697-ea43-e063-6394a90a59631
200224montelukast 10 MG Oral TabletSCD26d11120-5697-ea43-e063-6394a90a59631
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY26d11120-5697-ea43-e063-6394a90a59631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-725-0155111072501100 TABLET, COATED in 1 BOTTLE (55111-725-01) 2012-08-060000-00-00NoNoCurrent
55111-725-10551110725101000 TABLET, COATED in 1 BOTTLE (55111-725-10) 2012-08-060000-00-00NoNoCurrent
55111-725-305511107253030 TABLET, COATED in 1 BOTTLE (55111-725-30) 2012-08-060000-00-00NoNoCurrent
55111-725-785511107257810 BLISTER PACK in 1 CARTON (55111-725-78) / 10 TABLET, COATED in 1 BLISTER PACK (55111-725-79) 10 blister pack2012-08-060000-00-00NoNoCurrent
55111-725-795511107257910 in 1 BLISTER PACKHistorical
55111-725-905511107259090 TABLET, COATED in 1 BOTTLE (55111-725-90) 2012-08-060000-00-00NoNoCurrent