FDA.reportPublic FDA data

Montelukast

Product NDC
68788-8099
11-digit product format
687888099
Labeler code
68788
Product ID
68788-8099_b29d7b77-d758-4b93-bf05-76cf2632d9cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202843
Marketing category
ANDA
Marketing start
2021-10-06
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
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
68788-8099-3Montelukast30 in 1 BOTTLETABLET, FILM COATED305
68788-8099-6Montelukast60 in 1 BOTTLETABLET, FILM COATED605
68788-8099-9Montelukast90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8099-3EA - Each68788-809956fd5fa6-513f-4b2e-bab4-245b23ad49fb12021-11-09
68788-8099-6EA - Each68788-8099c4894191-f2a2-43a8-87c0-a5bcd83bfb4a12021-11-09
68788-8099-9EA - Each68788-8099c0cdbd6f-eabf-4656-9df4-f69282071bc612021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8099MONTELUKAST TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240724_94642db1-5c75-44c4-92b4-8385b486df82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN94642db1-5c75-44c4-92b4-8385b486df825
200224montelukast 10 MG Oral TabletSCD94642db1-5c75-44c4-92b4-8385b486df825
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY94642db1-5c75-44c4-92b4-8385b486df825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8099-36878880990330 TABLET, FILM COATED in 1 BOTTLE (68788-8099-3) 2021-10-060000-00-00NoNoCurrent
68788-8099-66878880990660 TABLET, FILM COATED in 1 BOTTLE (68788-8099-6) 2021-10-060000-00-00NoNoCurrent
68788-8099-96878880990990 TABLET, FILM COATED in 1 BOTTLE (68788-8099-9) 2021-10-060000-00-00NoNoCurrent