Montelukast Sodium

Product NDC

68788-6410

11-digit product format

687886410

Labeler code

68788

Product ID

68788-6410_b236cb89-e463-431c-b29e-903590e57075

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Montelukast Sodium

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Preferred Pharmaceuticals Inc.

Application

ANDA202096

Marketing category

ANDA

Marketing start

2016-06-08

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

2018-12-31

Current FDA listing

Historical FDA.report record