Isosorbide Dinitrate

Product NDC
63629-9593
11-digit product format
636299593
Labeler code
63629
Product ID
63629-9593_d39aa53f-52e2-45c6-93de-150f47e14bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211290
Marketing category
ANDA
Marketing start
2021-12-21
Substance
ISOSORBIDE DINITRATE
Active strength
40 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
63629-9593-163629959301100 TABLET in 1 BOTTLE (63629-9593-1) 100 tablet2021-12-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Isosorbide Dinitrate Tablets, USP Rx onlyBryant Ranch Prepack2024-10-08HUMAN PRESCRIPTION DRUG LABEL102