Isosorbide Mononitrate

Product NDC
68084-591
11-digit product format
680840591
Labeler code
68084
Product ID
68084-591_e0df8ac2-63fe-39ba-e053-2a95a90ab9c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075155
Marketing category
ANDA
Marketing start
2013-03-04
Marketing end
2023-10-31
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-591-01EA - Each68084-591b7a0d9dd-933e-4daa-8ea4-dd11a870151c12013-04-01
68084-591-11EA - Each68084-59194f5eb2f-dbbd-482e-b16e-ff892610f38212013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-591-0168084059101100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-591-01) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-591-11) 100 blister pack2013-03-040000-00-00NoNoCurrent