FDA.reportPublic FDA data

Montelukast

Product NDC
50090-6108
11-digit product format
500906108
Labeler code
50090
Product ID
50090-6108_eeb0e0ae-31b8-4954-ac31-de5c082b18eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
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
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6108-0Montelukast30 in 1 BOTTLETABLET, FILM COATED303
50090-6108-1Montelukast90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6108-0EA - Each50090-6108cf77b456-e34e-43fd-9b22-a6d151c8816a12022-11-07
50090-6108-1EA - Each50090-6108e197cac4-ed7d-46e2-9b2e-379fc08a767812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6108MONTELUKAST (MONTELUKAST) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231103_6741830f-5d90-4066-bc3b-065059bc150d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN6741830f-5d90-4066-bc3b-065059bc150d3
200224montelukast 10 MG Oral TabletSCD6741830f-5d90-4066-bc3b-065059bc150d3
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY6741830f-5d90-4066-bc3b-065059bc150d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6108-05009061080030 TABLET, FILM COATED in 1 BOTTLE (50090-6108-0) 2022-09-280000-00-00NoNoCurrent
50090-6108-15009061080190 TABLET, FILM COATED in 1 BOTTLE (50090-6108-1) 2022-09-280000-00-00NoNoCurrent