Montelukast Sodium

Product NDC

68788-9439

11-digit product format

687889439

Labeler code

68788

Product ID

68788-9439_e486a9da-5021-47e9-ae8d-bb0f76655a0d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA091588

Marketing category

ANDA

Marketing start

2014-05-05

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

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record