Montelukast Sodium

Product NDC

0378-5201

11-digit product format

003785201

Labeler code

0378

Product ID

0378-5201_57fcd11a-014e-421b-965c-187b64f28676

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA079103

Marketing category

ANDA

Marketing start

2012-08-03

Marketing end

2019-09-30

Substance

MONTELUKAST SODIUM

Active strength

10 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