FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
71335-2194
11-digit product format
713352194
Labeler code
71335
Product ID
71335-2194_a862daa7-dcfb-4f6e-90db-b712a7829fe8
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
30 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 MONONITRATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLX1OH63030
Rxcui317110

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
71335-2194-1Isosorbide Mononitrate30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE30102
71335-2194-2Isosorbide Mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE90102
71335-2194-3Isosorbide Mononitrate60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60102
71335-2194-4Isosorbide Mononitrate120 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE120102
71335-2194-5Isosorbide Mononitrate10 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10102
71335-2194-6Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2194ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 6 package rows20240420_441ddd35-6cb8-44d0-8009-1635390ede83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN441ddd35-6cb8-44d0-8009-1635390ede83102
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD441ddd35-6cb8-44d0-8009-1635390ede83102
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY441ddd35-6cb8-44d0-8009-1635390ede83102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2194-17133521940130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-1) 2024-04-030000-00-00NoNoCurrent
71335-2194-27133521940290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-2) 2023-09-060000-00-00NoNoCurrent
71335-2194-37133521940360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-3) 2023-04-110000-00-00NoNoCurrent
71335-2194-471335219404120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-4) 2022-11-180000-00-00NoNoCurrent
71335-2194-57133521940510 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-5) 2024-04-030000-00-00NoNoCurrent
71335-2194-671335219406100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2194-6) 2024-04-03NoNoHistorical