Montelukast Sodium

Product NDC

0378-5205

11-digit product format

003785205

Labeler code

0378

Product ID

0378-5205_57fcd11a-014e-421b-965c-187b64f28676

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, CHEWABLE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc

Application

ANDA079142

Marketing category

ANDA

Marketing start

2012-08-03

Marketing end

2019-03-31

Substance

MONTELUKAST SOD

Active strength

5 mg/1

Pharmacologic classes

Leukotriene Rec

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record