FDA.reportPublic FDA data

montelukast sodium

Product NDC
68788-8617
11-digit product format
687888617
Labeler code
68788
Product ID
68788-8617_68ee9209-7a6b-4f51-9252-2e22baaa58f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204290
Marketing category
ANDA
Marketing start
2024-03-28
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

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
68788-8617-3montelukast sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
68788-8617-6montelukast sodium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
68788-8617-9montelukast sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8617-3EA - Each68788-86173ca79944-8f7a-4dc7-87fe-ae2b6c28f21b12024-06-10
68788-8617-6EA - Each68788-861762c3ba00-a202-464c-a509-f0b01e0de4d012024-06-10
68788-8617-9EA - Each68788-861727fe57c3-93d4-4553-85ce-655d4b792b3c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8617MONTELUKAST SODIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240405_1eeb3123-9e93-4681-8096-800a7c7acf8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN1eeb3123-9e93-4681-8096-800a7c7acf8a2
200224montelukast 10 MG Oral TabletSCD1eeb3123-9e93-4681-8096-800a7c7acf8a2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY1eeb3123-9e93-4681-8096-800a7c7acf8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8617-36878886170330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-3) 2024-03-28NoNoHistorical
68788-8617-66878886170660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-6) 2024-03-28NoNoHistorical
68788-8617-96878886170990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8617-9) 2024-03-28NoNoHistorical