FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
71610-337
11-digit product format
716100337
Labeler code
71610
Product ID
71610-337_e6ce8fcb-476d-40f5-b38f-be1f7253353e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-05
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
2020-12-31
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
71610-337-302023-01-30C16284748780-1f386c64a-0d7d-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets, USP
71610-337-602023-01-30C16284748780-1f386c64a-0d7d-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets, USP
71610-337-802023-01-30C16284748780-1f386c64a-0d7d-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-337-30Isosorbide Mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE301
71610-337-60Isosorbide Mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE901
71610-337-80Isosorbide Mononitrate180 in 1 BOTTLETABLET, EXTENDED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-337-30EA - Each71610-3373d87bc1e-90a4-401e-b8b8-d6f1ae29e98f12019-10-07
71610-337-60EA - Each71610-3374d3e8c4b-f21d-429b-b7b4-c88f3aeee9d312019-10-07
71610-337-80EA - Each71610-3378d8c5281-8751-4367-bde4-052dd1a453c712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-337ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20190831_9ea70e22-9687-40eb-9388-744768a2b33a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN9ea70e22-9687-40eb-9388-744768a2b33a1
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN9ea70e22-9687-40eb-9388-744768a2b33a1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN9ea70e22-9687-40eb-9388-744768a2b33a1
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD9ea70e22-9687-40eb-9388-744768a2b33a1
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD9ea70e22-9687-40eb-9388-744768a2b33a1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD9ea70e22-9687-40eb-9388-744768a2b33a1
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY9ea70e22-9687-40eb-9388-744768a2b33a1
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY9ea70e22-9687-40eb-9388-744768a2b33a1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY9ea70e22-9687-40eb-9388-744768a2b33a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-337-307161003373030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-337-30) 2019-08-150000-00-00NoNoCurrent
71610-337-607161003376090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-337-60) 2019-08-150000-00-00NoNoCurrent
71610-337-8071610033780180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-337-80) 2019-08-150000-00-00NoNoCurrent