Montelukast Sodium

Product NDC

68645-466

11-digit product format

686450466

Labeler code

68645

Product ID

68645-466_5f0df6bc-1032-47f9-a901-1a47abc3d153

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Montelukast Sodium

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Legacy Pharmaceutical Pac

Application

ANDA201582

Marketing category

ANDA

Marketing start

2012-08-06

Marketing end

2019-03-31

Substance

MONTELUKAST SOD

Active strength

10 mg/1

Pharmacologic classes

Leukotriene Rec

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record