MONTELUKAST

Product NDC

68071-1652

11-digit product format

680711652

Labeler code

68071

Product ID

68071-1652_66d5e6a0-7bec-5344-e053-2a91aa0aa48c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

MONTELUKAST

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NuCare Pharmaceuticals,Inc.

Application

ANDA202859

Marketing category

ANDA

Marketing start

2014-12-01

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

2019-12-31

Current FDA listing

Historical FDA.report record