FDA.reportPublic FDA data

ISOSORBIDE MONONITRATE

Product NDC
59651-540
11-digit product format
596510540
Labeler code
59651
Product ID
59651-540_55810c9d-1140-40b8-a297-210a84afc05a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOSORBIDE MONONITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216557
Marketing category
ANDA
Marketing start
2022-11-07
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
Rxcui311196, 317110, 353538

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
59651-540-01ISOSORBIDE MONONITRATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
59651-540-05ISOSORBIDE MONONITRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-540-01EA - Each59651-54059191bae-40c3-4f21-93d0-6f96929f5c0412023-03-13
59651-540-05EA - Each59651-540c1e3506a-2f2f-4edf-9bc8-711367b6c28612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-540ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]1Current NDC, Legacy NDC, 2 package rows20221111_55810c9d-1140-40b8-a297-210a84afc05a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN55810c9d-1140-40b8-a297-210a84afc05a1
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN55810c9d-1140-40b8-a297-210a84afc05a1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN26a5a118-23f1-b5cd-e063-6394a90a130b1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN55810c9d-1140-40b8-a297-210a84afc05a1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN5a8164a3-56e2-4b9b-8718-0423b4b4958f1
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD55810c9d-1140-40b8-a297-210a84afc05a1
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD55810c9d-1140-40b8-a297-210a84afc05a1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD26a5a118-23f1-b5cd-e063-6394a90a130b1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD55810c9d-1140-40b8-a297-210a84afc05a1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD5a8164a3-56e2-4b9b-8718-0423b4b4958f1
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY55810c9d-1140-40b8-a297-210a84afc05a1
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY55810c9d-1140-40b8-a297-210a84afc05a1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY26a5a118-23f1-b5cd-e063-6394a90a130b1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY55810c9d-1140-40b8-a297-210a84afc05a1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY5a8164a3-56e2-4b9b-8718-0423b4b4958f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-540-0159651054001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-540-01) 2022-11-070000-00-00NoNoCurrent
59651-540-0559651054005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-540-05) 2022-11-070000-00-00NoNoCurrent