isosorbide mononitrate

Product NDC
50090-2077
11-digit product format
500902077
Labeler code
50090
Product ID
50090-2077_bf63bf7c-2d05-40b3-b50b-6054ea40415b
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
60 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
50090-2077-0isosorbide mononitrate30 in 1 BOTTLETABLET, EXTENDED RELEASE305
50090-2077-1isosorbide mononitrate100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
50090-2077-2isosorbide mononitrate90 in 1 BOTTLETABLET, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2077-0EA - Each50090-20776f15805a-e314-47ac-943c-a1c10fb9e65112019-02-13
50090-2077-1EA - Each50090-2077d99dd1d8-e4f8-4ca1-bfe4-20d1b93d9ad512019-02-13
50090-2077-2EA - Each50090-207764069ef1-fa05-4ccb-9646-682d8477405212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2077ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 3 package rows20181211_b14942c1-6162-4582-bc2c-2ff07a344dbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
353538isosorbide mononitrate 60 MG 24HR Extended Release Oral TabletPSNb14942c1-6162-4582-bc2c-2ff07a344dbd5
35353824 HR isosorbide mononitrate 60 MG Extended Release Oral TabletSCDb14942c1-6162-4582-bc2c-2ff07a344dbd5
353538isosorbide mononitrate 60 MG 24 HR Extended Release Oral TabletSYb14942c1-6162-4582-bc2c-2ff07a344dbd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2077-05009020770030 in 1 BOTTLEHistorical
50090-2077-150090207701100 in 1 BOTTLEHistorical
50090-2077-25009020770290 in 1 BOTTLEHistorical