Isosorbide Dinitrate

Product NDC
43353-141
11-digit product format
433530141
Labeler code
43353
Product ID
43353-141_2f4be110-f156-465a-861d-fe406e0fd037
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA087537
Marketing category
ANDA
Marketing start
2015-09-04
Marketing end
0000-00-00
Substance
ISOSORBIDE DINITRATE
Active strength
20 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-141-60EA - Each43353-141c30c0ebc-0b86-40ea-a888-6270301df31a12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-141ISOSORBIDE DINITRATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160707_7effb3dd-d0e6-4212-8e21-87e259330f6c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-141-604335301416090 TABLET in 1 BOTTLE (43353-141-60) 90 tablet2016-02-200000-00-00NoNoCurrent