isosorbide mononitrate

Product NDC
50090-0787
11-digit product format
500900787
Labeler code
50090
Product ID
50090-0787_687bcb34-71fe-46b9-8f77-3c22f43878e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0787-0isosorbide mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE306
50090-0787-1isosorbide mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0787-1EA - Each50090-078749c1a405-cd7e-4d97-99d6-9921ae195a0c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0787ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20171026_5a3baddd-1c7f-40a6-b475-ca227a28ef30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317110isosorbide mononitrate 30 MG 24HR Extended Release Oral TabletPSN5a3baddd-1c7f-40a6-b475-ca227a28ef306
31711024 HR isosorbide mononitrate 30 MG Extended Release Oral TabletSCD5a3baddd-1c7f-40a6-b475-ca227a28ef306
317110isosorbide mononitrate 30 MG 24 HR Extended Release Oral TabletSY5a3baddd-1c7f-40a6-b475-ca227a28ef306

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0787-05009007870030 in 1 BOTTLEHistorical
50090-0787-150090078701100 in 1 BOTTLEHistorical