ISOSORBIDE MONONITRATE

Product NDC
55154-7292
11-digit product format
551547292
Labeler code
55154
Product ID
55154-7292_92197742-097e-45e9-991c-4ec077e3b507
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ISOSORBIDE MONONITRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA200495
Marketing category
ANDA
Marketing start
2015-01-05
Substance
ISOSORBIDE MONONITRATE
Active strength
60 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
LX1OH63030ISOSORBIDE MONONITRATE16051-77-7ISOSORBIDE MONONITRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-7292-05515472920010 BLISTER PACK in 1 BAG (55154-7292-0) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2015-01-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Isosorbide Mononitrate Extended-Release Tablets, USP Rx onlyCardinal Health 107, LLC2025-05-05HUMAN PRESCRIPTION DRUG LABEL9