Montelukast Sodium

Product NDC

0615-7983

11-digit product format

006157983

Labeler code

0615

Product ID

0615-7983_e36d02c8-d5a3-4067-b85e-3a25e97972bf

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Montelukast Sodium

Dosage form

TABLET

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA090655

Marketing category

ANDA

Marketing start

2012-08-03

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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record