Isosorbide
Isosorbide is a nitrate medicine, available as isosorbide mononitrate and isosorbide dinitrate tablets, used to prevent angina (chest pain) caused by coronary artery disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 60 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Isosorbide is a nitrate that prevents angina (chest pain) from coronary artery disease by relaxing veins to ease the heart's workload and widening the arteries that feed the heart; an older standby, often added to other angina medicines, it has been around since about 1978 and is available as a generic. It is generally well tolerated once the early headache fades, with dizziness and flushing close behind. Never combine it with erectile dysfunction drugs such as sildenafil or tadalafil, or with riociguat, since the mix can drop blood pressure severely and cause fainting or reduced blood flow to the heart. It cannot stop an angina attack already under way.
Clinical pearls
- The daily medicine-free gap is deliberate, because without it your body builds tolerance and the drug stops working well.
- Swallow extended-release tablets (Imdur) whole on waking with about half a glass of fluid, and never chew or crush them.
- Stand up slowly, especially if you also take a calcium channel blocker, a combination that has caused marked dizziness on standing.
- Limit alcohol, which adds to the blood-vessel-widening effect and can turn mild lightheadedness into fainting.
Patient information guide A plain-language walkthrough of Isosorbide, written from its FDA label.
What Isosorbide is used for
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Isosorbide products are used for angina pectoris due to coronary artery disease.
- Isosorbide mononitrate extended-release tablets: prevention of angina.
- Isosorbide mononitrate tablets: prevention and treatment of angina.
- Isosorbide dinitrate tablets: prevention of angina.
None of these oral products works quickly enough to stop an angina attack in progress.
How Isosorbide works
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Isosorbide mononitrate is the main active form of isosorbide dinitrate. Like all organic nitrates, it relaxes the smooth muscle in blood vessel walls. Veins widen the most, so less blood returns to the heart and the heart has less pressure to work against.
Arteries relax too, which lowers blood pressure and the heart's workload. The coronary arteries also widen.
Isosorbide dosage
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All of these are swallowed by mouth. The schedule depends on the product.
- Isosorbide mononitrate extended-release tablets: once daily in the morning on waking. Swallow whole with about half a glass of fluid.
- Isosorbide mononitrate tablets: twice daily, with doses seven hours apart.
- Isosorbide dinitrate tablets: two or three times daily, with a dose-free interval of at least 14 hours.
Follow your prescriber and label directions exactly. The daily break from the medicine helps prevent tolerance.
Dosing details from the FDA-approved label
From the Isosorbide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Isosorbide mononitrate tablets (immediate-release)
- 20 mg twice daily, with the doses seven hours apart
- Maximum: Doses above 20 mg twice a day (with the doses seven hours apart) have not been adequately studied
- Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function
- Isosorbide mononitrate tablets, persons of particularly small stature
- Starting dose of 5 mg (1/2 tablet of the 10 mg strength), to be increased to at least 10 mg by the second or third day of therapy
- Doses of 5 mg twice a day are clearly effective for only the first day of the regimen
- Isosorbide dinitrate tablets, starting dose
- 5 mg to 20 mg, two or three times daily
- A daily dose-free interval of at least 14 hours is advisable to minimize tolerance
- Isosorbide dinitrate tablets, maintenance therapy
- 10 mg to 40 mg, two or three times daily
- Some patients may require higher doses
- A daily dose-free interval of at least 14 hours is advisable to minimize tolerance
- Isosorbide mononitrate extended-release tablets, starting dose
- 30 mg (a single 30 mg tablet or 1/2 of a 60 mg tablet) or 60 mg (a single tablet) once daily, taken in the morning on arising
- Do not chew or crush; swallow with a half-glassful of fluid. Do not break the 30 mg tablet
- Isosorbide mononitrate extended-release tablets, dose increase
- After several days, may be increased to 120 mg (a single 120 mg tablet or two 60 mg tablets) once daily
- Rarely, 240 mg may be required
Read the label’s full dosing text
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.
Read the full Dosage and Administration section on DailyMed →
Isosorbide side effects
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The most common side effects are headache and dizziness.
Common side effects
- Headache (the most common; often fades with continued treatment)
- Dizziness
- Low blood pressure
- Flushing
- Nausea
- Weakness or tiredness
- Fast or pounding heartbeat
When to get medical help
- Fainting or severe lightheadedness, especially when standing up
- Chest pain that gets worse
- Fast or irregular heartbeat
- Severe or persistent throbbing headache with confusion
- Signs of an overdose, such as severe dizziness, vomiting, shortness of breath, or cold clammy skin
- Trouble getting enough oxygen despite normal breathing, which can signal methemoglobinemia (a blood problem reported with nitrates)
Isosorbide warnings and precautions
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- Erectile dysfunction drugs (sildenafil, tadalafil, vardenafil) and riociguat must not be used with isosorbide. The combination can cause dangerously low blood pressure.
- Isosorbide dinitrate immediate-release tablets are not recommended for acute heart attack or heart failure. Their effects are hard to reverse quickly.
- Tolerance can develop if nitrate levels stay constant over 24 hours, so a daily dose-free period matters.
- Methemoglobinemia, a blood problem that limits oxygen delivery, has been reported with nitrates.
Isosorbide interactions
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Isosorbide can add to the effects of other blood-vessel-widening drugs.
- Erectile dysfunction drugs: can cause severe low blood pressure. Contraindicated.
- Riociguat: can cause low blood pressure. Contraindicated.
- Alcohol: adds to the blood pressure-lowering effect.
- Other vasodilators: effects may be additive.
- Calcium channel blockers: marked dizziness on standing has been reported, and dose changes may be needed.
Interactions listed in the FDA-approved label
From the Isosorbide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Phosphodiesterase inhibitors (any form): Concomitant use with isosorbide mononitrate is contraindicated. See CONTRAINDICATIONS
- Riociguat (soluble guanylate cyclase stimulator): Concomitant use with isosorbide mononitrate is contraindicated. See CONTRAINDICATIONS
- Other vasodilators: The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators.
- Alcohol: Alcohol has been found to exhibit additive vasodilating effects.
- Calcium channel blockers: Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Read the label’s full interactions text
Drug Interactions Concomitant use of isosorbide mononitrate with phosphodiesterase inhibitors in any form is contraindicated (see CONTRAINDICATIONS ). Concomitant use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS ). The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Isosorbide
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- Do not take isosorbide dinitrate if you are allergic to it or its ingredients.
- Do not take it with erectile dysfunction medicines or riociguat.
- Tell your prescriber if you have heart failure or a recent heart attack.
- For isosorbide mononitrate tablets, the label says no dose adjustment is needed for older adults or for people with kidney or liver problems.
- Share a list of all your medicines, including other heart and blood pressure drugs.
Isosorbide overdose
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Too much isosorbide can cause very low blood pressure, a pounding headache, confusion, fever, vomiting, fainting, shortness of breath, slow heartbeat, seizures and coma. Seek emergency help right away. Treatment focuses on raising blood volume, such as elevating the legs or giving IV fluids. Methemoglobinemia can also occur and is treated with methylene blue.
What Isosorbide does in the body
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Nitrates lose their anti-angina effect if blood levels stay steady for 24 hours. Raising the dose does not overcome this tolerance. Effects return only after the drug has been out of the body for several hours. That is why regimens include a daily nitrate-free interval, such as two doses seven hours apart for isosorbide mononitrate tablets.
How your body processes Isosorbide
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Isosorbide mononitrate is absorbed rapidly and almost completely, with peak levels in about 30 to 60 minutes for immediate-release forms. Food does not significantly change absorption. Its half-life is about 5 hours. The liver breaks it down into inactive products, and these leave mainly in the urine. Kidney, liver or heart problems and older age did not meaningfully change how it clears.
How to store Isosorbide
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Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Isosorbide
22 supplements and herbal products have documented interactions with Isosorbide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 9
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Isosorbide: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Isosorbide — the kind of thing our pharmacy team would talk through with you at the counter.
What is isosorbide for?
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How should I take it?
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Why do I get headaches?
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Can I take it with Viagra or similar medicines?
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Can I drink alcohol?
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When should I call for help?
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Is Isosorbide available over the counter?
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When was Isosorbide first available?
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Who makes Isosorbide?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Isosorbide on HelloPharmacist
Isosorbide forms and strengths (how it comes)
Isosorbide is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Isosorbide Mononitrate tablets are used to prevent and treat angina due to coronary artery disease.
- Isosorbide Dinitrate tablets are used to prevent angina due to coronary artery disease.
- Isosorbide Mononitrate tablets are taken twice daily, with doses about seven hours apart.
- Isosorbide Dinitrate tablets are taken two or three times daily, with a dose-free period of at least 14 hours each day.
Extended-release tablet
How this form is used
- Isosorbide Mononitrate extended-release tablets are used to prevent angina due to coronary artery disease.
- Isosorbide Mononitrate extended-release tablets are taken once daily in the morning on waking.
- Isosorbide Mononitrate extended-release tablets should be swallowed with about half a glass of fluid, not chewed or crushed.
Isosorbide on the U.S. market: products, makers and brands
How Isosorbide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
34 companies list 114 Isosorbide product records with the FDA, mostly as tablet, extended-release tablet; the earliest marketing or approval year on record is 1959. Brand names on the directory include Dilatrate-SR, Isordil, Monoket and 6 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Isosorbide is used (Medicaid data)
A general measure of how commonly Isosorbide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Isosorbide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Isosorbide prescribed? Of the 1,601 medications we measure, Isosorbide ranks #251 by Medicaid prescriptions — more than 84% of them.
Utilization by Isosorbide product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
24 HR isosorbide mononitrate 30 MG Extended Release Oral Tablet Most dispensed
Summed across the 16 of 112 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 317110
24 HR isosorbide mononitrate 60 MG Extended Release Oral Tablet
Summed across the 9 of 96 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 353538
24 HR isosorbide mononitrate 120 MG Extended Release Oral Tablet
Summed across the 5 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311196
isosorbide mononitrate 10 MG Oral Tablet
Summed across the 13 of 46 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311192
isosorbide mononitrate 20 MG Oral Tablet
Summed across the 12 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311197
Other Isosorbide products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 11 of 32 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Isosorbide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 66 of 343 listed Isosorbide NDCs with Medicaid activity.
Compare Isosorbide products
A representative set of FDA-listed product records for Isosorbide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release tablet | ||||
| 30 mg | Oral | A-S Medication Solutions × 4 listings | ANDA | View NDC → |
| 60 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 30 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 60 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 30 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC × 2 listings | ANDA | View NDC → |
| 60 mg | Oral | Aphena Pharma Solutions - Tennessee, LLC | ANDA | View NDC → |
| 30 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 60 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 120 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 30 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 60 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 30 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 60 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 30 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 60 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 120 mg | Oral | Chartwell RX, LLC | ANDA | View NDC → |
| 30 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 60 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 30 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 60 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 120 mg | Oral | Edenbridge Pharmaceuticals LLC. | ANDA | View NDC → |
| 30 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 60 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 120 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 💊Tablet | ||||
| 10 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Actavis Pharma, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 10 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 20 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 30 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 40 mg | Oral | Advagen Pharma Ltd | ANDA | View NDC → |
| 10 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 20 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 10 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | AvPAK | ANDA | View NDC → |
| 10 mg | Oral | AvPAK | ANDA | View NDC → |
| 20 mg | Oral | AvPAK | ANDA | View NDC → |
| 5 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 10 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 20 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 30 mg | Oral | BluePoint Laboratories | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 10 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 20 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 10 mg | Oral | Coupler LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 20 mg | Oral | Coupler LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 5 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 30 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Endo USA, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Genus Lifesciences Inc. | ANDA | View NDC → |
| 20 mg | Oral | Genus Lifesciences Inc. | ANDA | View NDC → |
| 5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 10 mg | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 20 mg | Oral | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 10 mg | Oral | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 20 mg | Oral | Lannett Company, Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 20 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 20 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 30 mg | Oral | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | View NDC → |
| 5 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 10 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 20 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 30 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 5 mg | Oral | Oceanside Pharmaceuticals | NDA | View NDC → |
| 40 mg | Oral | Oceanside Pharmaceuticals | NDA | View NDC → |
| 10 mg | Oral | Omnivium Pharmaceuticals Llc. | NDA AUTHORIZED GENERIC | View NDC → |
| 20 mg | Oral | Omnivium Pharmaceuticals Llc. | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 20 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 20 mg | Oral | Proficient Rx LP | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 5 mg | Oral | Sandoz Inc. | ANDA | View NDC → |
| 10 mg | Oral | Sandoz Inc. | ANDA | View NDC → |
| 20 mg | Oral | Sandoz Inc. | ANDA | View NDC → |
| 5 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 10 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 20 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 30 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 40 mg | Oral | Zydus Lifesciences Limited | ANDA | View NDC → |
| 5 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 10 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 20 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 30 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
| 40 mg | Oral | Zydus Pharmaceuticals (USA) Inc. | ANDA | View NDC → |
Showing 99 of 114 products — FDA National Drug Code Directory. See every product, package size and price: browse all 114 Isosorbide NDCs →
Isosorbide side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Isosorbide — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Isosorbide in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Isosorbide FDA approval history
How Isosorbide went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Isosorbide recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Isosorbide recalls since July 2021.
✅No Isosorbide recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 6057 4 dose forms · 14 strengths
-
Dose form (SCDF) Extended Release Oral Capsule RxCUI 631842No current FDA listingClinical drug / strength (SCD) 24 HR isosorbide mononitrate 25 MGRxCUI 41176024 HR isosorbide mononitrate 40 MGRxCUI 41176124 HR isosorbide mononitrate 50 MGRxCUI 41176424 HR isosorbide mononitrate 60 MGRxCUI 411763 -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 631894In current FDA listingsClinical drug / strength (SCD) 24 HR isosorbide mononitrate 120 MGRxCUI 31119624 HR isosorbide mononitrate 25 MGRxCUI 43385824 HR isosorbide mononitrate 30 MGRxCUI 31711024 HR isosorbide mononitrate 40 MGRxCUI 43388024 HR isosorbide mononitrate 50 MGRxCUI 43388124 HR isosorbide mononitrate 60 MGRxCUI 353538 -
Dose form (SCDF) Oral Solution RxCUI 370719No current FDA listingClinical drug / strength (SCD) 450 MG/MLRxCUI 311190 -
Dose form (SCDF) Oral Tablet RxCUI 631993In current FDA listingsClinical drug / strength (SCD) mononitrate 10 MGRxCUI 311192mononitrate 20 MGRxCUI 311197mononitrate 40 MGRxCUI 381054
Look up RxCUI 6057 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Isosorbide supply and shortage status
Whether Isosorbide is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Isosorbide costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 10 mg | $0.154 per tablet | NDC details & price history |
| Tablet · Oral | 20 mg | $0.199 per tablet | NDC details & price history |
| Tablet · Oral | 5 mg | $0.177 per tablet | NDC details & price history |
| Tablet · Oral | 40 mg | $3.31 per tablet | NDC details & price history |
| Tablet, Extended Release · Oral | 120 mg | $0.166 per tablet | NDC details & price history |
| Tablet | 10 mg | $2.40 per tablet | NDC details & price history |
| Tablet | 20 mg | $2.29 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Isosorbide brand names
Isosorbide is sold under 9 brand names in the FDA directory — Dilatrate-SR, Isordil, Monoket, Imdur and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Isosorbide: manufacturers and labelers
34 companies list Isosorbide products with the FDA. By number of product records, the largest are Golden State Medical Supply, Inc., A-S Medication Solutions, Advagen Pharma Ltd. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 10 more on the FDA NDC directory.
Isosorbide drug class (RxNorm)
Isosorbide belongs to the Nitrate Vasodilator class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Isosorbide page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. BluePoint Laboratories is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →