Isosorbide Mononitrate

Product NDC
70934-972
11-digit product format
709340972
Labeler code
70934
Product ID
70934-972_dfdc580f-d76c-6a73-e053-2995a90a71e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA075522
Marketing category
ANDA
Marketing start
2022-05-25
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-972-307093409723030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-972-30) 2022-05-250000-00-00NoNoCurrent