Isosorbide Mononitrate

Product NDC
68084-592
11-digit product format
680840592
Labeler code
68084
Product ID
68084-592_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
60 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
68084-592-01EA - Each68084-592dc568734-e368-4735-8771-73e9fff3a06d12013-04-01
68084-592-11EA - Each68084-59272f7019b-2396-457c-a79a-2ac47c8cd83812013-04-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-592-0168084059201100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-592-01) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68084-592-11) 100 blister pack2013-03-040000-00-00NoNoCurrent