Isosorbide Dinitrate

Product NDC
0615-8157
11-digit product format
006158157
Labeler code
0615
Product ID
0615-8157_18a1dd7e-c5be-474d-bccd-4466e0c0f1df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA086925
Marketing category
ANDA
Marketing start
1979-12-22
Marketing end
0000-00-00
Substance
ISOSORBIDE DINITRATE
Active strength
10 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8157-390061581573930 TABLET in 1 BLISTER PACK (0615-8157-39) 30 tablet2019-06-110000-00-00NoNoCurrent