Montelukast Sodium

Product NDC
50090-2176
11-digit product format
500902176
Labeler code
50090
Product ID
50090-2176_8e5ccffa-436e-4d9b-962f-2e5fc118ab3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202717
Marketing category
ANDA
Marketing start
2013-04-11
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2176MONTELUKAST SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]18Legacy NDC20240531_67d5a739-f6b8-4d7a-93bf-d6af89dbdd68.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2176-05009021760030 TABLET, FILM COATED in 1 BOTTLE (50090-2176-0) 2015-10-230000-00-00NoNoCurrent
50090-2176-15009021760190 TABLET, FILM COATED in 1 BOTTLE (50090-2176-1) 2015-10-230000-00-00NoNoCurrent