SINGULAIR

Product NDC

63629-3701

11-digit product format

636293701

Labeler code

63629

Product ID

63629-3701_a8054858-c322-4f42-ae25-127247706b57

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

NDA020830

Marketing category

NDA

Marketing start

1998-02-20

Marketing end

0000-00-00

Substance

MONTELUKAST SODIUM

Active strength

5 mg/1

Pharmacologic classes

Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record