FDA.reportPublic FDA data

Montelukast

Product NDC
72865-175
11-digit product format
728650175
Labeler code
72865
Product ID
72865-175_f26fa301-e121-03c1-e053-2a95a90ab2e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA202843
Marketing category
ANDA
Marketing start
2021-02-11
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
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
72865-175-10Montelukast1000 in 1 BOTTLETABLET, FILM COATED10002
72865-175-30Montelukast30 in 1 BOTTLETABLET, FILM COATED302
72865-175-90Montelukast90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-175MONTELUKAST (MONTELUKAST) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 3 package rows20230117_82d65eea-c7c9-4e16-9176-46c43f00f0f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN82d65eea-c7c9-4e16-9176-46c43f00f0f62
200224montelukast 10 MG Oral TabletSCD82d65eea-c7c9-4e16-9176-46c43f00f0f62
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY82d65eea-c7c9-4e16-9176-46c43f00f0f62
200224montelukast sodium 10 MG Oral TabletPSN4fe3c0d4-94ff-43ca-9d24-54676fe593fe1
200224montelukast 10 MG Oral TabletSCD4fe3c0d4-94ff-43ca-9d24-54676fe593fe1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY4fe3c0d4-94ff-43ca-9d24-54676fe593fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72865-175-10728650175101000 TABLET, FILM COATED in 1 BOTTLE (72865-175-10) 2021-02-110000-00-00NoNoCurrent
72865-175-307286501753030 TABLET, FILM COATED in 1 BOTTLE (72865-175-30) 2021-02-110000-00-00NoNoCurrent
72865-175-907286501759090 TABLET, FILM COATED in 1 BOTTLE (72865-175-90) 2021-02-110000-00-00NoNoCurrent