Isosorbide Mononitrate ER

Product NDC
61919-758
11-digit product format
619190758
Labeler code
61919
Product ID
61919-758_7ea39fc2-e910-527b-e053-2a91aa0a2de1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct Rx
Application
ANDA200270
Marketing category
ANDA
Marketing start
2019-01-04
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
2020-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
LX1OH63030ISOSORBIDE MONONITRATE16051-77-7ISOSORBIDE MONONITRATE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-758-306191907583030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-758-30) 2019-01-040000-00-00NoNoCurrent