isosorbide mononitrate 10 mg Tablet, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nitrate Vasodilator class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Isosorbide immediate-release tablets are used for the management of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Isosorbide extended-release (long-acting) tablets and extended-release capsules are used for the management of chest pain in people who have coronary artery disease. Isosorbide can only be used to prevent angina; it cannot be used to treat an episode of angina once it has begun. Isosorbide is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not ne...
Read the full MedlinePlus article ↗- Isosorbide is designed to prevent chest pain (angina) from starting in the first place, not to stop an attack that's already happening. It works by relaxing and widening your blood...
- What exactly does this medication do — will it stop my chest pain when it happens?
- Yes, headaches are very common when you first start isosorbide — they happen because the medication widens blood vessels, including in your head. The good news is that headaches us...
- I keep getting headaches since starting this — is that normal, and will it go away?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Isosorbide Mononitrate — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII U6XF9NP8HM
Aluminum stearate is a salt made from aluminum and stearic acid, a fatty substance. It works as a lubricant and glidant to help powder flow smoothly during manufacturing and tablet production.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
-
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.205 | $20.50 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.01 | $100.95 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| isosorbide mononitrate 10 mgthis 62175-0106-01 | Lannett | 100 tablets | $0.205 | AB | FDA listed | — |
| Isosorbide Mononitrate 10 mg 00228-2631-11 | Actavis | 100 tablets | $2.648 | — | Availability likely | +1192% |
| Isosorbide Mononitrate 10 mg 62559-0252-01 | ANI | 100 tablets | $2.648 | AB | Availability likely | +1192% |
| isosorbide mononitrate 10 mg 81665-0102-10 | OMNIVIUM | 100 tablets | $2.648 | AB | Availability likely | +1192% |
| Isosorbide Mononitrate 10 mg 64950-0250-01 | Genus | 100 tablets | — | AB | FDA listed | — |
| isosorbide mononitrate 10 mg 67046-1577-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Isosorbide Mononitrate 10 mg 67046-1687-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62175-0106-01 You're viewing this | 100 TABLET in 1 BOTTLE (62175-106-01) | 1993-06-30 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Isosorbide Mononitrate Tablets 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.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: The recommended regimen of Isosorbide Mononitrate Tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function.
As noted above ( Clinical Pharmacology ), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for Isosorbide Mononitrate Tablets provides a daily nitrate-free interval to minimize the development of tolerance. As also noted under Clinical Pharmacology , well-controlled studies have shown that tolerance to Isosorbide Mononitrate Tablets occurs to some extent when using the twice-daily regimen in which the two doses are given seven hours apart.
This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least seven hours after the second dose. The duration (if any) of antianginal activity beyond fourteen hours has not been studied. In clinical trials, isosorbide mononitrate has been administered in a variety of regimens and doses.
Doses above 20 mg twice a day (with the doses seven hours apart) have not been adequately studied. Doses of 5 mg twice a day are clearly effective (effectiveness based on exercise tolerance) for only the first day of a twice-a-day (with doses 7 hours apart) regimen.
⛔ Contraindications ▾
CONTRAINDICATIONS: Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia.
Do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
⚠️ Warnings ▾
WARNINGS: Amplification of the vasodilatory effects of isosorbide mononitrate by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy. The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad.
The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment. Frequency of Adverse Reactions (Discontinuations)* 6 Placebo-Controlled Studies Dose Placebo 5 mg 10 mg 20 mg Patients 160 54 52 159 Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%) Fatigue 2% (0%) 0% (0%) 4% (0%) 1% (0%) Upper Respiratory Infection <1% (0%) 0% (0%) 4% (0%) 1% (0%) Pain <1% (0%) 4% (0%) 0% (0%) <1% (0%) Dizziness 1% (0%) 0% (0%) 0% (0%) 4% (0%) Nausea <1% (0%) 0% (0%) 0% (0%) 3% (2%) Increased Cough <1% (0%) 0% (0%) 2% (0%) <1% (0%) Rash 0% (0%) 2% (2%) 0% (0%) <1% (0%) Abdominal Pain <1% (0%) 0% (0%) 2% (0%) 0% (0%) Allergic Reaction 0% (0%) 0% (0%) 2% (0%) 0% (0%) Cardiovascular Disorder 0% (0%) 2% (0%) 0% (0%) 0% (0%) Chest Pain <1% (0%) 0% (0%) 2% (0%) <1% (0%) Diarrhea 0% (0%) 0% (0%) 2% (0%) 0% (0%) Flushing 0% (0%) 0% (0%) 2% (0%) 0% (0%) Emotional Lability 0% (0%) 2% (0%) 0% (0%) 0% (0%) Pruritus 1% (0%) 2% (2%) 0% (0%) 0% (0%) Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were: Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia.
Dermatologic: sweating. Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight. Genitourinary: prostatic disorder.
Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, paresthesia, susurrus aurium. Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo. Respiratory: asthma, dyspnea, sinusitis.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see under Overdosage .
🆘 Overdosage ▾
OVERDOSAGE: Hemodynamic Effects: The ill effects of isosorbide mononitrate overdose are generally the results of isosorbide mononitrate’s capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures and death.
Laboratory determinations of serum levels of isosorbide mononitrate and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of isosorbide mononitrate overdose. There are no data suggesting what dose of isosorbide mononitrate is likely to be life-threatening in humans. In rats and mice, there is significant lethality at oral doses of 1965 mg/kg and 2581 mg/kg, respectively.
No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of isosorbide mononitrate. Isosorbide mononitrate is significantly removed from the blood during hemodialysis. No specific antagonist to the vasodilator effects of isosorbide mononitrate is known, and no intervention has been subject to controlled study as a therapy of isosorbide mononitrate overdose.
Because the hypotension associated with isosorbide mononitrate overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward an increase in central fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline of similar fluid may also be necessary. The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.
In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of isosorbide mononitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required. Methemoglobinemia: Methemoglobinemia has been reported in patients receiving other organic nitrates, and it probably could also occur as a side effect of isosorbide mononitrate.
Certainly nitrate ions liberated during metabolism of isosorbide mononitrate can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moiety of isosorbide mononitrate is quantitatively applied to oxidation of hemoglobin, about 2 mg/kg of isosorbide mononitrate should be required before any of these patients manifests clinically significant (≥10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of isosorbide mononitrate.
In one study in which 36 patients received 2-4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 7.8 – 11.1 mg of isosorbide mononitrate per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo. Notwithstanding these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible.
Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial p02. Classically, met…
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of isosorbide mononitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload).
Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction and coronary dilatation remains undefined.
Pharmacodynamics: Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously-delivered nitrates.
In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy. Attempts to overcome tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their antianginal efficacy been restored.
The drug-free interval sufficient to avoid tolerance to isosorbide mononitrate has not been completely defined. In the only regimen of twice-daily isosorbide mononitrate that has been shown to avoid development of tolerance, the two doses of Isosorbide Mononitrate Tablets are given 7 hours apart, so there is a gap of 17 hours between the second dose of each day and the first dose of the next day. Taking account of the relatively long half-life of isosorbide mononitrate this result is consistent with those obtained for other organic nitrates.
The asymmetric twice-daily regimen of Isosorbide Mononitrate Tablets successfully avoided significant rebound/withdrawal effects. The incidence and magnitude of such phenomena have appeared, in studies of other nitrates, to be highly dependent upon the schedule of nitrate administration. Pharmacokinetics: Isosorbide mononitrate is rapidly and completely absorbed from the gastrointestinal tract.
In humans, isosorbide mononitrate is not subject to first pass metabolism in the liver. The absolute bioavailability of isosorbide mononitrate from Isosorbide Mononitrate Tablets is nearly 100%. Peak plasma concentrations usually occur in about 30-60 minutes.
Isosorbide mononitrate exhibits dose proportionality over the recommended dose range. Food does not significantly affect the absorption or bioavailability of Isosorbide Mononitrate Tablets. Metoprolol coadministration did not change the pharmacokinetics of isosorbide mononitrate.
The volume of distribution is approximately
0.6L/kg. Plasma protein binding of isosorbide mononitrate was found to be less than 5%. When radiolabelled isosorbide mononitrate was administered to humans in order to elucidate the metabolic fate, about half of the dose was found denitrated and renally excreted as isosorbide and sorbitol.
One quarter of the dose was accounted for as conjugates of the parent drug in the urine. None of these metabolites is vasoactive. Only 2% of the dose was excreted as unchanged drug.
The overall elimination half-life of isosorbide mononitrate is about 5 hours. The rate of clearance is the same in healthy young adults, in patients with various degrees of renal, hepatic or cardiac dysfunction and in the elderly. When radiolabelled isosorbide mononitrate was administered to humans, 93% of the dose was excreted within 48 hours into the urine.
R…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Isosorbide Mononitrate 10 mg Tablets, USP are white, round, scored and engraved "10" on one side and engraved "KU 106" on the other. They are supplied as follows: Bottles of 100 NDC 62175-106-01 Isosorbide Mononitrate 20 mg Tablets, USP are white, round, scored and engraved "20" on one side and engraved "KU 107" on the other. They are supplied as follows: Bottles of 100 NDC 62175-107-01 Store at 20° - 30°C (68° - 86°F) [See USP].
Keep tightly closed. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIA71194G Rev.
06/20
📋 Description ▾
DESCRIPTION: Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C 6 H 9 NO 6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula: Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets.
Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate. Chemical Structure