Montelukast Sodium

Product NDC

70518-0684

11-digit product format

705180684

Labeler code

70518

Product ID

70518-0684_8ac1e728-fba6-3350-e053-2a95a90aad3a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Montelukast Sodium

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA078605

Marketing category

ANDA

Marketing start

2017-08-16

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