isosorbide mononitrate

Product NDC

68788-6863

11-digit product format

687886863

Labeler code

68788

Product ID

68788-6863_bb938c13-0db4-4a17-a9f4-b7d0b40de3f6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

isosorbide mononitrate

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Preferred Pharmaceuticals Inc.

Application

ANDA075155

Marketing category

ANDA

Marketing start

2016-12-27

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