Montelukast Sodium

Product NDC
70518-1784
11-digit product format
705181784
Labeler code
70518
Product ID
70518-1784_9681298b-7e4b-59e7-e053-2995a90a163d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201582
Marketing category
ANDA
Marketing start
2019-01-09
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1784MONTELUKAST SODIUM TABLET, COATED [REMEDYREPACK INC.]7Legacy NDC20250228_d267f492-43f6-45ba-8421-82ae2771788b.zip