Isosorbide Mononitrate

Product NDC
50090-4009
11-digit product format
500904009
Labeler code
50090
Product ID
50090-4009_35543b1f-e71e-42e3-a89e-5a5e849a6c5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4009-0EA - Each50090-4009583188c2-8fc0-427e-94eb-1dc3ede2b9aa12021-12-08
50090-4009-1EA - Each50090-400939ca8559-ddee-476c-82eb-03cbc3486dba12021-12-08
50090-4009-2EA - Each50090-4009c103539f-6bf3-417c-89c5-002f3bf7076412021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4009ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Legacy NDC20230712_9561a974-0ef4-4b56-bf0a-1ad600c25db5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4009-05009040090030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4009-0) 2018-12-280000-00-00NoNoCurrent
50090-4009-150090400901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4009-1) 2018-12-280000-00-00NoNoCurrent
50090-4009-25009040090290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4009-2) 2014-11-280000-00-00NoNoCurrent