Prescription medicine
Isosorbide mononitrate First approved as Ismo
Isosorbide mononitrate (Ismo) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $0.0688 per isosorbide mononit ER 30 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the isosorbide mononitrate FDA label on DailyMed (effective May 11, 2026, Torrent Pharmaceuticals Limited); the NDA 19091 record on Drugs@FDA; every isosorbide mononitrate label on DailyMed.
Highlights of the record
FDA label of May 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIsosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease.
Forms and strengths
- 10 mg
- 20 mg
- 30 mg
- 60 mg
- 120 mg
Extended-release tablet; tablet.
On the market
- Earliest approval on file
- December 30, 1991 Ismo, Promius Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first September 22, 1998; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 21 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0688 per tablet Isosorbide mononit ER 30 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 3 more by firms not listed as its makers
- FAERS reports
- 20,616 through July 30, 2026
What is isosorbide mononitrate used for?
From the label: indications and usageIsosorbide 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.
Conditions named in the indications of isosorbide mononitrate's FDA labels, with every medicine labeled for each:
From other isosorbide mononitrate labelsAngina: INDICATIONS AND USAGE Isosorbide mononitrate extended-release tablets, USP are indicated for the prevention of angina pectoris due to coronary artery disease.
FDA pharmacologic class: Nitrate Vasodilator.
Source: FDA drug label (ISOSORBIDE MONONITRATE), Torrent Pharmaceuticals Limited, effective May 11, 2026 (SPL set 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c), via openFDA; the full label on DailyMed
Is there a generic for isosorbide mononitrate (Ismo)?
The FDA approved the first generic isosorbide mononitrate on September 22, 1998. 20 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists isosorbide mononitrate from 21 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 1998 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for isosorbide mononitrate (Ismo)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0688 per Isosorbide mononit ER 30 mg tablet, down 4% from $0.0714 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Isosorbide mononit ER 30 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Isosorbide mononit 10 mg tablet | Generic | $2.40 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $72.12 | -17% |
| Isosorbide mononit 20 mg tablet | Generic | $2.29 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $68.74 | -32% |
| Isosorbide mononit ER 120 mg | Generic | $0.166 per unit | n/a | -4% |
| Isosorbide mononit ER 30 mg tablet | Generic | $0.0688 per tablet | $2.06 | -4% |
| Isosorbide mononit ER 60 mg tablet | Generic | $0.0969 per tablet | $2.91 | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has isosorbide mononitrate been recalled?
The FDA's Enforcement Report lists 3 recalls naming isosorbide mononitrate since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of isosorbide mononitrate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22 … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the isosorbide mononitrate label say about other medicines?
The isosorbide mononitrate label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Riociguat | contraindications | Do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. |
| Sildenafil | warnings | WARNINGS Amplification of the vasodilatory effects of isosorbide mononitrate by sildenafil can result in severe hypotension. |
| Tadalafil | contraindications | Do not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. |
| Vardenafil | contraindications | Do not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. |
Source: FDA drug label (ISOSORBIDE MONONITRATE), Torrent Pharmaceuticals Limited, effective May 11, 2026 (SPL set 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c), via openFDA; the full label on DailyMed
What do FAERS reports show for isosorbide mononitrate?
The FDA Adverse Event Reporting System holds 20,616 reports that list isosorbide mononitrate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,596 are coded as a death and 9,840 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as isosorbide mononitrate?
4 other medicines are given the same way (oral) and in the same FDA class as isosorbide mononitrate or labeled mainly for the same use (angina), the same class first. Angina lists all 21 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Isosorbide dinitrate | Angina | 17 labelers | $0.154 per tablet 10 mg tablet | No current entry |
| Nitroglycerin | Angina | 2 labelers | $23.52 per gram 400 mcg spray | A presentation being discontinued |
| Ranolazine | Angina | 28 labelers | $0.165 per tablet 500 mg tablet | No current entry |
| Nadolol | Angina | 16 labelers | $0.147 per tablet 20 mg tablet | No current entry |
Every medicine labeled for the same conditions as isosorbide mononitrate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does isosorbide mononitrate compare with medicines for the same use?
3 side-by-side pages set isosorbide mononitrate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to isosorbide mononitrate
- 4 medicines for the same use
- Other nitrate vasodilators
- the pharmacologic class, with prices and generics
- Isosorbide mononitrate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other