Quick answers
- What is Isosorbide mononitrate used for?
- The FDA-approved label (Isosorbide Mononitrate, Coupler LLC, September 5, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isosorbide mononitrate have a boxed warning?
- No. None of the 37 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Isosorbide mononitrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isosorbide mononitrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Isosorbide mononitrate?
- 24 companies list prescription products of Isosorbide mononitrate in the FDA NDC Directory, including Coupler LLC, A-S Medication Solutions and Edenbridge Pharmaceuticals LLC..
What Isosorbide mononitrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Isosorbide Mononitrate, Coupler LLC, effective September 5, 2025. Read the full label on DailyMed →
The FDA has 37 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 37 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 59 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| isosorbide mononitrate 10 mg tablet | Generic | $2.19 per tablet |
| isosorbide mononitrate 120 mg tablet, extended release | Generic | $0.1668 per tablet |
| isosorbide mononitrate 20 mg tablet | Generic | $2.15 per tablet |
| isosorbide mononitrate 30 mg tablet, extended release | Generic | $0.0714 per tablet |
| isosorbide mononitrate 60 mg tablet, extended release | Generic | $0.0974 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Coupler LLC5 products
- A-S Medication Solutions5 products
- Edenbridge Pharmaceuticals LLC.3 products
- Ingenus Pharmaceuticals, LLC3 products
- Aurobindo Pharma Limited3 products
- Torrent Pharmaceuticals Limited3 products
- Shandong New Time Pharmaceutical Co., Ltd.3 products
- Chartwell RX, LLC3 products
- Golden State Medical Supply, Inc.3 products
- Bryant Ranch Prepack3 products
- Aphena Pharma Solutions - Tennessee, LLC3 products
- American Health Packaging2 products
- Genus Lifesciences Inc.2 products
- Cardinal Health 107, LLC2 products
- Lannett Company, Inc.2 products
- Major Pharmaceuticals2 products
- Actavis Pharma, Inc.2 products
- NCS HealthCare of KY, LLC dba Vangard Labs2 products
- Omnivium Pharmaceuticals LLC.2 products
- ANI Pharmaceuticals, Inc.2 products
- Northwind Health Company, LLC1 product
- Remedyrepack Inc.1 product
- Proficient Rx LP1 product
- NuCare Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020215 MONOKET | Omnivium Pharms | June 30, 1993 | 14, latest February 1, 2022 2022: Manufacturing (CMC) · 2014: Labeling · 2002: Manufacturing (CMC) |
Generic approvals (9)
- ANDA075037Genus · October 30, 1998
- ANDA075147Ani Pharms · November 27, 1998
- ANDA075522Dexcel Ltd · April 17, 2000
- ANDA200270Torrent Pharms · June 3, 2011
- ANDA200495Torrent Pharms · June 3, 2011
- ANDA210822Dexcel Ltd · August 29, 2018
- ANDA210918Riconpharma LLC · November 5, 2018
- ANDA214115Shandong · April 29, 2022
- ANDA216557Aurobindo Pharma · November 7, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Isosorbide Mononitrate, Coupler LLC, effective September 5, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →