isosorbide mononitrate

Product NDC
50436-3944
11-digit product format
504363944
Labeler code
50436
Product ID
50436-3944_07387db8-293b-4ae4-8625-c8e89360a293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unit Dose Services
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
50436-3944-1isosorbide mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
50436-3944-3isosorbide mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOSORBIDE MONONITRATEACTIVE INGREDIENTLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]2
ISOSORBIDE MONONITRATEACTIVE MOIETYLX1OH63030ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3944ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20170307_c550c0a4-3217-40ca-a5f5-51ab27e11005.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNc550c0a4-3217-40ca-a5f5-51ab27e110055
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDc550c0a4-3217-40ca-a5f5-51ab27e110055
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYc550c0a4-3217-40ca-a5f5-51ab27e110055

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3944-15043639440130 in 1 BOTTLEHistorical
50436-3944-35043639440390 in 1 BOTTLEHistorical