isosorbide mononitrate

Product NDC
68151-1420
11-digit product format
681511420
Labeler code
68151
Product ID
68151-1420_cc752fd3-a51c-4770-bc08-2421ba4efaab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
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
E
Listing certified through
2018-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-1420-62020-01-31C16284748780-19d75b9d1-0e07-f424-e053-dadaa90a57ceIsosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1420-6isosorbide mononitrate1 in 1 PACKAGETABLET, EXTENDED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1420ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20160304_2fdef9a2-61b6-43cc-8780-11e9f8bcc6f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN2fdef9a2-61b6-43cc-8780-11e9f8bcc6f22
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD2fdef9a2-61b6-43cc-8780-11e9f8bcc6f22
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY2fdef9a2-61b6-43cc-8780-11e9f8bcc6f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1420-6681511420061 in 1 PACKAGEHistorical