Montelukast Sodium

Product NDC

68788-8988

11-digit product format

687888988

Labeler code

68788

Product ID

68788-8988_83415087-ed71-403a-b111-b3ac0959e179

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

2016-02-01

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