Montelukast Sodium

Product NDC
70518-0331
11-digit product format
705180331
Labeler code
70518
Product ID
70518-0331_83d2adad-ce6e-8ed4-e053-2991aa0a6c35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202717
Marketing category
ANDA
Marketing start
2017-03-17
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