ISOSORBIDE DINITRATE

Product NDC
82804-117
11-digit product format
828040117
Labeler code
82804
Product ID
82804-117_33d14f59-3ae8-4414-b826-06274cf0f3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA215723
Marketing category
ANDA
Marketing start
2022-07-08
Substance
ISOSORBIDE DINITRATE
Active strength
10 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
IA7306519NISOSORBIDE DINITRATE87-33-2ISOSORBIDE DINITRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-117-908280401179090 TABLET in 1 BOTTLE (82804-117-90) 90 tablet2024-07-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Isosorbide Dinitrate TabletsProficient Rx LP2024-07-01HUMAN PRESCRIPTION DRUG LABEL1