Montelukast Sodium

Product NDC

0603-4654

11-digit product format

006034654

Labeler code

0603

Product ID

0603-4654_ab3aeb32-71f3-4b01-b964-83065fed74f9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Par Pharmaceutical

Application

ANDA091588

Marketing category

ANDA

Marketing start

2012-08-03

Marketing end

2020-01-31

Substance

MONTELUKAST SODIUM

Active strength

5 mg/1

Pharmacologic classes

Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record