Isosorbide Mononitrate

Product NDC
71335-2532
11-digit product format
713352532
Labeler code
71335
Product ID
71335-2532_334cb4f5-b33c-4871-9777-7bd9d0f4cab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075522
Marketing category
ANDA
Marketing start
2010-06-07
Substance
ISOSORBIDE MONONITRATE
Active strength
60 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 MONONITRATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui353538

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
71335-2532-1Isosorbide Mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
71335-2532-2Isosorbide Mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71335-2532-3Isosorbide Mononitrate60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71335-2532-4Isosorbide Mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE902
71335-2532-5Isosorbide Mononitrate10 in 1 BOTTLETABLET, EXTENDED RELEASE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2532ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 5 package rows20241128_cd60ded0-01d9-4a51-a8ad-cdfeb27d88fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNcd60ded0-01d9-4a51-a8ad-cdfeb27d88fb2
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDcd60ded0-01d9-4a51-a8ad-cdfeb27d88fb2
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYcd60ded0-01d9-4a51-a8ad-cdfeb27d88fb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2532-171335253201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-1) 2024-11-26NoNoHistorical
71335-2532-27133525320230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-2) 2024-11-26NoNoHistorical
71335-2532-37133525320360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-3) 2024-11-26NoNoHistorical
71335-2532-47133525320490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-4) 2024-11-26NoNoHistorical
71335-2532-57133525320510 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-5) 2024-11-26NoNoHistorical