ISOSORBIDE MONONITRATE

Product NDC
55154-7291
11-digit product format
551547291
Labeler code
55154
Product ID
55154-7291_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
ANDA200270
Marketing category
ANDA
Marketing start
2015-01-05
Substance
ISOSORBIDE MONONITRATE
Active strength
30 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
55154-7291-05515472910010 BLISTER PACK in 1 BAG (55154-7291-0) / 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