FDA.reportPublic FDA data

Isosorbide Mononitrate

Product NDC
50090-4047
11-digit product format
500904047
Labeler code
50090
Product ID
50090-4047_19c08063-f9b8-4052-88a7-2efeda86a527
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075522
Marketing category
ANDA
Marketing start
2017-01-05
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cc3f7505-fd5d-aab9-1128-173349f98a63Product name420230113
f23201a1-1f10-4748-0041-3c03fbb37cfbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4047-02023-01-30C16284748780-1f386c64a-1ae5-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets, USP Rx only
50090-4047-12023-01-30C16284748780-1f386c64a-1ae5-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets, USP Rx only
50090-4047-22023-01-30C16284748780-1f386c64a-1ae5-0266-e053-dadaa90a7c1aIsosorbide Mononitrate Extended-Release Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4047-0Isosorbide Mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
50090-4047-1Isosorbide Mononitrate100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1005
50090-4047-2Isosorbide Mononitrate90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4047-0EA - Each50090-4047fb33fd12-9434-489b-9b61-99d19b7848fa12022-01-06
50090-4047-1EA - Each50090-4047659dbb07-547f-4875-8afe-d472a1d6d50812022-01-06
50090-4047-2EA - Each50090-4047d6cfd7c1-92e8-440c-a736-4d9d8176750c12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4047ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 3 package rows20210417_00270f4b-53e4-482b-9f99-aee57ace7831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN00270f4b-53e4-482b-9f99-aee57ace78315
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD00270f4b-53e4-482b-9f99-aee57ace78315
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY00270f4b-53e4-482b-9f99-aee57ace78315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4047-05009040470030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4047-0) 2019-01-110000-00-00NoNoCurrent
50090-4047-150090404701100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4047-1) 2017-01-050000-00-00NoNoCurrent
50090-4047-25009040470290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4047-2) 2017-01-050000-00-00NoNoCurrent