Montelukast Sodium

Product NDC
68071-4054
11-digit product format
680714054
Labeler code
68071
Product ID
68071-4054_56f6247e-5d43-0924-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090984
Marketing category
ANDA
Marketing start
2012-08-03
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
4 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