FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
71335-2192
11-digit product format
713352192
Labeler code
71335
Product ID
71335-2192_79752f3a-c401-46d7-84a5-9383a04c792d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-13
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
71335-2192-1Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE100102
71335-2192-2Isosorbide Mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30102
71335-2192-3Isosorbide Mononitrate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60102
71335-2192-4Isosorbide Mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90102
71335-2192-5Isosorbide Mononitrate10 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2192-1EA - Each71335-219276fc2d0c-78c4-443b-957f-6151a9b6315f12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2192ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 5 package rows20240608_96420729-2bc7-4d03-9c51-f786ea678998.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN96420729-2bc7-4d03-9c51-f786ea678998102
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD96420729-2bc7-4d03-9c51-f786ea678998102
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY96420729-2bc7-4d03-9c51-f786ea678998102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2192-171335219201100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-1) 2022-12-010000-00-00NoNoCurrent
71335-2192-27133521920230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-2) 2022-12-010000-00-00NoNoCurrent
71335-2192-37133521920360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-3) 2022-12-010000-00-00NoNoCurrent
71335-2192-47133521920490 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-4) 2022-12-010000-00-00NoNoCurrent
71335-2192-57133521920510 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2192-5) 2022-12-010000-00-00NoNoCurrent