FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
51407-208
11-digit product format
514070208
Labeler code
51407
Product ID
51407-208_26ab803d-04f8-b766-e063-6394a90a117f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA210918
Marketing category
ANDA
Marketing start
2018-11-05
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
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
51407-208-01Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1008
51407-208-05Isosorbide Mononitrate500 in 1 BOTTLETABLET, EXTENDED RELEASE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-208-01EA - Each51407-2089062e951-d9fb-4e34-a24e-d1c6cb85176f12019-06-19
51407-208-05EA - Each51407-2089acb5f0b-24ac-4190-872c-77ccc4e977b712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-208ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 2 package rows20241114_86be0e85-5337-bee4-e053-2a91aa0a8158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN18cf36bc-e73f-4274-b381-c2f2aa02f57d2
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD18cf36bc-e73f-4274-b381-c2f2aa02f57d2
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY18cf36bc-e73f-4274-b381-c2f2aa02f57d2
311196isosorbide mononitrate 120 MG 24HR Extended Release Oral TabletPSN9ea70e22-9687-40eb-9388-744768a2b33a1
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN9ea70e22-9687-40eb-9388-744768a2b33a1
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSN9ea70e22-9687-40eb-9388-744768a2b33a1
31119624 HR isosorbide mononitrate 120 MG Extended Release Oral TabletSCD9ea70e22-9687-40eb-9388-744768a2b33a1
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD9ea70e22-9687-40eb-9388-744768a2b33a1
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCD9ea70e22-9687-40eb-9388-744768a2b33a1
311196isosorbide mononitrate 120 MG 24 HR Extended Release Oral TabletSY9ea70e22-9687-40eb-9388-744768a2b33a1
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY9ea70e22-9687-40eb-9388-744768a2b33a1
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSY9ea70e22-9687-40eb-9388-744768a2b33a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-208-0151407020801100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-208-01) 2019-04-190000-00-00NoNoCurrent
51407-208-0551407020805500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-208-05) 2019-04-190000-00-00NoNoCurrent