ISOSORBIDE MONONITRATE

Product NDC

0904-6451

11-digit product format

009046451

Labeler code

0904

Product ID

0904-6451_476da661-b1f6-4f61-876e-b829cfbc50fc

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ISOSORBIDE MONONITRATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Major Pharmaceuticals

Application

ANDA200495

Marketing category

ANDA

Marketing start

2015-01-05

Marketing end

0000-00-00

Substance

ISOSORBIDE MONONITRATE

Active strength

120 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