Montelukast

Product NDC

70518-1031

11-digit product format

705181031

Labeler code

70518

Product ID

70518-1031_8ffb0413-29f2-c9e0-e053-2a95a90a9015

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Montelukast

Dosage form

TABLET

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA203366

Marketing category

ANDA

Marketing start

2018-02-21

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record