Isosorbide Mononitrate

Product NDC

0615-7757

11-digit product format

006157757

Labeler code

0615

Product ID

0615-7757_f6d7be3e-a108-4617-8864-352d233e85b0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Isosorbide Mononitrate

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA090598

Marketing category

ANDA

Marketing start

2010-08-11

Marketing end

0000-00-00

Substance

ISOSORBIDE MONONITRATE

Active strength

60 mg/1

Pharmacologic classes

Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record