montelukast sodium

Product NDC
68071-2486
11-digit product format
680712486
Labeler code
68071
Product ID
68071-2486_c8a99278-21e3-c517-e053-2a95a90ade37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204093
Marketing category
ANDA
Marketing start
2015-05-27
Marketing end
0000-00-00
Substance
MONTELUKAST
Active strength
5 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2486-92023-01-30C16284748780-1f386c649-a0c7-0266-e053-dadaa90a7c1ac8a9c0f7-7e6e-58a6-e053-2a95a90a06e0

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2486MONTELUKAST SODIUM TABLET, CHEWABLE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210804_c8a9c0f7-7e6e-58a6-e053-2a95a90a06e0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2486-96807124860990 TABLET, CHEWABLE in 1 BOTTLE (68071-2486-9) 2021-08-030000-00-00NoNoCurrent