FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
50742-176
11-digit product format
507420176
Labeler code
50742
Product ID
50742-176_1548dff4-f987-4dbe-87ec-f4e9d1d60366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
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
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
50742-176-01Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1009
50742-176-05Isosorbide Mononitrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-176-01EA - Each50742-176c9b6c7c2-3d34-4d5b-a64f-92dafc25335b12019-04-11
50742-176-05EA - Each50742-17610d200e5-cc34-4523-be5e-04ed3540284f12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-176ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]9Current NDC, Legacy NDC, 2 package rows20231121_c950760f-0e32-483f-96f2-eecaf057c0ec.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
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSNc950760f-0e32-483f-96f2-eecaf057c0ec9
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSNc950760f-0e32-483f-96f2-eecaf057c0ec9
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNc950760f-0e32-483f-96f2-eecaf057c0ec9
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCDc950760f-0e32-483f-96f2-eecaf057c0ec9
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCDc950760f-0e32-483f-96f2-eecaf057c0ec9
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDc950760f-0e32-483f-96f2-eecaf057c0ec9
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSYc950760f-0e32-483f-96f2-eecaf057c0ec9
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSYc950760f-0e32-483f-96f2-eecaf057c0ec9
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYc950760f-0e32-483f-96f2-eecaf057c0ec9
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN86be0e85-5337-bee4-e053-2a91aa0a81588
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN86be0e85-5337-bee4-e053-2a91aa0a81588
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN86be0e85-5337-bee4-e053-2a91aa0a81588
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD86be0e85-5337-bee4-e053-2a91aa0a81588
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD86be0e85-5337-bee4-e053-2a91aa0a81588
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD86be0e85-5337-bee4-e053-2a91aa0a81588
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY86be0e85-5337-bee4-e053-2a91aa0a81588
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY86be0e85-5337-bee4-e053-2a91aa0a81588
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY86be0e85-5337-bee4-e053-2a91aa0a81588
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNbbbb2dda-b68e-4cae-bec5-04a4d8f1f40b1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDbbbb2dda-b68e-4cae-bec5-04a4d8f1f40b1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYbbbb2dda-b68e-4cae-bec5-04a4d8f1f40b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-176-0150742017601100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50742-176-01) 2018-11-130000-00-00NoNoCurrent
50742-176-0550742017605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-176-05) 2018-11-130000-00-00NoNoCurrent