Montelukast Sodium

Product NDC

0615-7748

11-digit product format

006157748

Labeler code

0615

Product ID

0615-7748_508c39f3-66a8-4db2-b1ec-87533ab2ca03

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Montelukast Sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA078605

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