isosorbide mononitrate

Product NDC
67544-236
11-digit product format
675440236
Labeler code
67544
Product ID
67544-236_ebfecd61-9a4e-4395-92bc-0af814c29d6f
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
30 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-236-09isosorbide mononitrate9000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90003
67544-236-30isosorbide mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE303
67544-236-56isosorbide mononitrate3000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30003
67544-236-60isosorbide mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE903
67544-236-99isosorbide mononitrate600 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-236-30EA - Each67544-236e3d8ee6b-5e90-4575-9f5b-33e03b565dae12013-02-13
67544-236-60EA - Each67544-236b3418cf4-9d56-49d5-a283-4aec58179fa812013-02-13
67544-236-99EA - Each67544-2365a434de9-842b-491c-bae5-58992ff67cae12014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-236ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 5 package rows20191227_06faac0a-d719-4b54-85df-fdf3a5c6599f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN06faac0a-d719-4b54-85df-fdf3a5c6599f3
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD06faac0a-d719-4b54-85df-fdf3a5c6599f3
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY06faac0a-d719-4b54-85df-fdf3a5c6599f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-236-09675440236099000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-09) 2014-03-010000-00-00NoNoCurrent
67544-236-306754402363030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-30) 2005-05-240000-00-00NoNoCurrent
67544-236-56675440236563000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-56) 2014-02-060000-00-00NoNoCurrent
67544-236-606754402366090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-60) 2005-02-030000-00-00NoNoCurrent
67544-236-9967544023699600 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (67544-236-99) 2014-03-010000-00-00NoNoCurrent