Montelukast Sodium

Product NDC

51079-223

11-digit product format

510790223

Labeler code

51079

Product ID

51079-223_7d000c0b-dd97-7415-e053-2a91aa0a3efa

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

montelukast sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA079103

Marketing category

ANDA

Marketing start

2012-08-28

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