isosorbide mononitrate

Product NDC
70518-2000
11-digit product format
705182000
Labeler code
70518
Product ID
70518-2000_c5994030-7a2c-c2d4-e053-2a95a90a6981
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020215
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-04-03
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
10 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2000-07051820000030 TABLET in 1 BLISTER PACK (70518-2000-0) 30 tablet2019-04-030000-00-00NoNoCurrent
70518-2000-17051820000190 TABLET in 1 BOTTLE, PLASTIC (70518-2000-1) 90 tablet2019-07-100000-00-00NoNoCurrent