FDA.reportPublic FDA data

isosorbide mononitrate

Product NDC
43353-917
11-digit product format
433530917
Labeler code
43353
Product ID
43353-917_fae6e18e-d0f1-4ab4-a332-9ea49f729be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
120 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
43353-917-052023-01-30C16284748780-1f386c649-e095-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-917-05isosorbide mononitrate4200 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE42002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-917-05EA - Each43353-9174a428bbf-5d70-4ead-961a-5c5b5fa775f412015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-917ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 1 package rows20191221_c4e579c9-2f31-4d5b-bac2-1261626277b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSNc4e579c9-2f31-4d5b-bac2-1261626277b22
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCDc4e579c9-2f31-4d5b-bac2-1261626277b22
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSYc4e579c9-2f31-4d5b-bac2-1261626277b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-917-05433530917054200 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-917-05) 2014-04-060000-00-00NoNoCurrent