Isosorbide Mononitrate

Product NDC

70934-183

11-digit product format

709340183

Labeler code

70934

Product ID

70934-183_9ae1a8ec-e2a3-e850-e053-2995a90a7e65

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Isosorbide Mononitrate

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Application

ANDA075522

Marketing category

ANDA

Marketing start

2018-10-23

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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record