FDA label
What is isosorbide mononitrate used for?
The FDA-approved uses of isosorbide mononitrate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.”
Run it in Rivvi
Which 2027 plans near you dropped or restricted isosorbide mononitrate?
Tier changes and new prior auth, step therapy or quantity limits, plan by plan.
Free to start. Opens Rivvi, the AI workspace for healthcare teams.
Isosorbide Mononitrate, tablet, extended release
Indications and Usage, quoted from the label by Torrent Pharmaceuticals Limited (ANDA200270). Cross-references to other label sections are left out.
Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Source: DailyMed label, set id 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c, version 13, effective May 11, 2026. NDC 13668-104, one of 45 listings for this product.
Isosorbide Mononitrate, tablet
Indications and Usage, quoted from the label by Genus Lifesciences Inc. (ANDA075037). Cross-references to other label sections are left out.
Isosorbide mononitrate tablets, USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Source: DailyMed label, set id 0d739bf3-0672-4504-9064-b39d6b200b47, version 1, effective April 9, 2026. NDC 64950-250, one of 7 listings for this product.
Questions
What is isosorbide mononitrate used for?
The FDA label says: “Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.”
What drug class is isosorbide mononitrate?
FDA lists isosorbide mononitrate in the Nitrate Vasodilator established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Isosorbide Mononitrate
- Is Isosorbide Mononitrate a controlled substance?Federal schedule
- Generic for ImdurFDA Orange Book
- Generic for IsmoFDA Orange Book
- Generic for MonoketFDA Orange Book
- Nitrate Vasodilators listFDA drug class
- NDC 0228-2620Isosorbide Mononitrate NDC record
- NDC 0228-2631Isosorbide Mononitrate NDC record
- NDC 0615-7767Isosorbide Mononitrate NDC record