Montelukast Sodium

Product NDC
50090-5403
11-digit product format
500905403
Labeler code
50090
Product ID
50090-5403_67d75630-d117-425a-b17e-83ddf933bce5
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5403-02023-02-07C16284748780-1f386c64a-1d53-0266-e053-dadaa90a7c1a50e0671d-db22-4814-ab7c-a3621206c82b
50090-5403-02023-01-30C16284748780-1f386c64a-1d53-0266-e053-dadaa90a7c1a50e0671d-db22-4814-ab7c-a3621206c82b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5403-0EA - Each50090-540366196f27-3c6b-484a-9ad9-46a8e669481012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5403MONTELUKAST SODIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Legacy NDC20240530_50e0671d-db22-4814-ab7c-a3621206c82b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5403-05009054030090 TABLET, FILM COATED in 1 BOTTLE (50090-5403-0) 2020-12-080000-00-00NoNoCurrent