Isosorbide Mononitrate

Product NDC

0615-5549

11-digit product format

006155549

Labeler code

0615

Product ID

0615-5549_20147b6e-d77f-4031-a5de-3f62383c7c14

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Isosorbide Mononitrate

Dosage form

TABLET

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA075037

Marketing category

ANDA

Marketing start

1998-10-30

Marketing end

0000-00-00

Substance

ISOSORBIDE MONONITRATE

Active strength

10 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