Isosorbide Mononitrate

Product NDC
71335-0037
11-digit product format
713350037
Labeler code
71335
Product ID
71335-0037_20566339-a0bc-477f-95c9-0be75f3ef7f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075522
Marketing category
ANDA
Marketing start
2010-06-07
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0037-1EA - Each71335-0037effd67dd-9123-445b-b4c1-3ea5b752aae012018-03-08
71335-0037-2EA - Each71335-0037c1ff8715-154d-47e6-8b3e-3d94d8b8e12412018-03-08
71335-0037-3EA - Each71335-003755ef0901-1655-465a-825b-aceb97624b2012018-03-08
71335-0037-4EA - Each71335-003793e6efbd-20dc-437c-98a2-4864ac56891b12018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0037-171335003701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0037-1) 2021-12-270000-00-00NoNoCurrent
71335-0037-27133500370230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0037-2) 2021-12-270000-00-00NoNoCurrent
71335-0037-37133500370360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0037-3) 2021-12-270000-00-00NoNoCurrent
71335-0037-47133500370490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0037-4) 2021-12-270000-00-00NoNoCurrent
71335-0037-57133500370510 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0037-5) 2021-12-270000-00-00NoNoCurrent