FDA.reportPublic FDA data

isosorbide mononitrate

Product NDC
63187-900
11-digit product format
631870900
Labeler code
63187
Product ID
63187-900_44ed966d-bf75-4379-84f4-b5270e2bb700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA020215
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1993-06-30
Substance
ISOSORBIDE MONONITRATE
Active strength
20 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
isosorbide mononitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE MONONITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui311197

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-900-30isosorbide mononitrate30 in 1 BOTTLETABLET303
63187-900-60isosorbide mononitrate60 in 1 BOTTLETABLET603
63187-900-90isosorbide mononitrate90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-900-30EA - Each63187-9001c39a684-fa89-485b-ba90-e6467790394412017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-900ISOSORBIDE MONONITRATE TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191108_f871dfa7-219f-4704-8e4d-215caeb7408d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311197isosorbide mononitrate 20 MG Oral TabletPSNf871dfa7-219f-4704-8e4d-215caeb7408d3
311197isosorbide mononitrate 20 MG Oral TabletSCDf871dfa7-219f-4704-8e4d-215caeb7408d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-900-306318709003030 TABLET in 1 BOTTLE (63187-900-30) 30 tablet2017-09-010000-00-00NoNoCurrent
63187-900-606318709006060 TABLET in 1 BOTTLE (63187-900-60) 60 tablet2017-09-010000-00-00NoNoCurrent
63187-900-906318709009090 TABLET in 1 BOTTLE (63187-900-90) 90 tablet2017-09-010000-00-00NoNoCurrent