isosorbide mononitrate

Product NDC

55700-123

11-digit product format

557000123

Labeler code

55700

Product ID

55700-123_77df121c-2754-431f-b730-eec91a7c51b9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

isosorbide mononitrate

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA075155

Marketing category

ANDA

Marketing start

1998-10-30

Marketing end

0000-00-00

Substance

ISOSORBIDE MONONITRATE

Active strength

30 mg/1

Pharmacologic classes

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

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record