Isosorbide Mononitrate

Product NDC
50090-5572
11-digit product format
500905572
Labeler code
50090
Product ID
50090-5572_fdeb2f81-58ce-43af-aaa4-215a72126254
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-13
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5572-0Isosorbide Mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE301
50090-5572-1Isosorbide Mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
50090-5572-2Isosorbide Mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5572ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 3 package rows20210710_bbbb2dda-b68e-4cae-bec5-04a4d8f1f40b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNbbbb2dda-b68e-4cae-bec5-04a4d8f1f40b1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDbbbb2dda-b68e-4cae-bec5-04a4d8f1f40b1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYbbbb2dda-b68e-4cae-bec5-04a4d8f1f40b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5572-05009055720030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5572-0) 2021-06-280000-00-00NoNoCurrent
50090-5572-150090557201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5572-1) 2021-06-280000-00-00NoNoCurrent
50090-5572-25009055720290 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5572-2) 2021-06-280000-00-00NoNoCurrent