FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
68788-8610
11-digit product format
687888610
Labeler code
68788
Product ID
68788-8610_4770cc7d-0fd7-4992-bd3e-f59c54cbd3b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA201515
Marketing category
ANDA
Marketing start
2024-03-20
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
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8610-3Montelukast Sodium30 in 1 BOTTLETABLET302
68788-8610-6Montelukast Sodium60 in 1 BOTTLETABLET602
68788-8610-9Montelukast Sodium90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8610-3EA - Each68788-8610b14369ad-be5c-4f70-b14b-3e5fc9b7cc8212024-06-10
68788-8610-6EA - Each68788-861003c14a2d-949a-42ab-ae5e-f7b043beb55612024-06-10
68788-8610-9EA - Each68788-86104089da6b-2323-494f-a16f-5b1a6bdc46fc12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8610MONTELUKAST SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240404_64a3b181-e8d8-4caf-9f1b-e0063d0bd94a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2
200224montelukast 10 MG Oral TabletSCD64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8610-36878886100330 TABLET in 1 BOTTLE (68788-8610-3) 30 tablet2024-03-20NoNoCurrent
68788-8610-66878886100660 TABLET in 1 BOTTLE (68788-8610-6) 60 tablet2024-03-20NoNoCurrent
68788-8610-96878886100990 TABLET in 1 BOTTLE (68788-8610-9) 90 tablet2024-03-20NoNoCurrent