FDA.reportPublic FDA data

Montelukast

Product NDC
68001-361
11-digit product format
680010361
Labeler code
68001
Product ID
68001-361_d9dbbe03-bcc4-1af7-e053-2a95a90a8053
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA203366
Marketing category
ANDA
Marketing start
2018-06-29
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-361-03Montelukast500 in 1 BOTTLETABLET5007
68001-361-04Montelukast30 in 1 BOTTLETABLET307
68001-361-05Montelukast90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-361-03EA - Each68001-3612730e7de-2fec-4241-a03e-f449b68a45d712018-10-11
68001-361-04EA - Each68001-36198fcd090-7ce2-44dd-a79b-77873569c2fc12018-10-11
68001-361-05EA - Each68001-361757b1da0-a7d7-4a65-a07a-6c1255454ddc12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-361MONTELUKAST TABLET [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 3 package rows20220315_4c411d3e-47b6-481b-b846-419ed4cbb947.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN4c411d3e-47b6-481b-b846-419ed4cbb9477
200224montelukast 10 MG Oral TabletSCD4c411d3e-47b6-481b-b846-419ed4cbb9477
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY4c411d3e-47b6-481b-b846-419ed4cbb9477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-361-0368001036103500 TABLET in 1 BOTTLE (68001-361-03) 500 tablet2018-06-290000-00-00NoNoCurrent
68001-361-046800103610430 TABLET in 1 BOTTLE (68001-361-04) 30 tablet2018-06-290000-00-00NoNoCurrent
68001-361-056800103610590 TABLET in 1 BOTTLE (68001-361-05) 90 tablet2018-06-290000-00-00NoNoCurrent