Prescription medicine
Isosorbide dinitrate First approved as Isordil
Isosorbide dinitrate (Isordil) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.154 per isosorbide dinitrate 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the isosorbide dinitrate FDA label on DailyMed (effective March 2, 2020, Oceanside Pharmaceuticals); the NDA 12093 record on Drugs@FDA; every isosorbide dinitrate label on DailyMed.
Highlights of the record
FDA label of March 2, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageIsosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 30 mg
- 40 mg
Tablet.
On the market
- Earliest approval on file
- November 9, 1959 Isordil, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first December 1, 1978; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 17 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.154 per tablet Isosorbide dinitrate 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest November 2, 2018; 3 more by firms not listed as its makers
- FAERS reports
- 19,415 through July 30, 2026
What is isosorbide dinitrate used for?
From the label: indications and usageIsosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Conditions named in the indications of isosorbide dinitrate's FDA labels, with every medicine labeled for each:
From other isosorbide dinitrate labelsAngina: INDICATIONS AND USAGE Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease.
FDA pharmacologic class: Nitrate Vasodilator.
Source: FDA drug label (Isosorbide Dinitrate), NDA012093 (Bausch), as published by Oceanside Pharmaceuticals, effective March 2, 2020 (SPL set 723d9f78-9d77-4575-af27-1aa117e6b8d7), via openFDA; the full label on DailyMed
Is there a generic for isosorbide dinitrate (Isordil)?
The FDA approved the first generic isosorbide dinitrate on December 1, 1978. 25 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 dinitrate from 17 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1959 earliest approval on file
- 1978 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 dinitrate (Isordil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.154 per Isosorbide dinitrate 10 mg tablet, down 18% from $0.189 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 dinitrate 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Isosorbide dinitrate 10 mg tablet | Generic | $0.154 per tablet | $4.63 | -18% |
| Isosorbide dinitrate 20 mg tablet | Generic | $0.199 per tablet | $5.97 | -6% |
| Isosorbide dinitrate 30 mg tablet | Generic | $0.281 per tablet | $8.42 | -20% |
| Isosorbide dinitrate 40 mg tablet | Generic | $3.31 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $99.31 | +28% |
| Isosorbide dinitrate 5 mg tablet | Generic | $0.177 per tablet | $5.30 | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has isosorbide dinitrate been recalled?
The FDA's Enforcement Report lists 7 recalls naming isosorbide dinitrate since 2013: 0 Class I (the most serious), 7 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 dinitrate 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 |
|---|---|---|---|
| November 2, 2018 | Class II | Sandoz Inc | Cross Contamination with Other Products |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the isosorbide dinitrate label say about other medicines?
The isosorbide dinitrate label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name isosorbide dinitrate. 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 Dinitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. |
| Sildenafil | contraindications | Do not use Isosorbide Dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. |
| Tadalafil | contraindications | Do not use Isosorbide Dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. |
| Vardenafil | contraindications | Do not use Isosorbide Dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. |
Source: FDA drug label (Isosorbide Dinitrate), NDA012093 (Bausch), as published by Oceanside Pharmaceuticals, effective March 2, 2020 (SPL set 723d9f78-9d77-4575-af27-1aa117e6b8d7), via openFDA; the full label on DailyMed
What do FAERS reports show for isosorbide dinitrate?
The FDA Adverse Event Reporting System holds 19,415 reports that list isosorbide dinitrate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,553 are coded as a death and 8,318 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 dinitrate?
4 other medicines are given the same way (oral) and in the same FDA class as isosorbide dinitrate 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 mononitrate | Angina | 21 labelers | $0.0688 per tablet 30 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 dinitrate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does isosorbide dinitrate compare with medicines for the same use?
1 side-by-side page set isosorbide dinitrate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to isosorbide dinitrate
- 4 medicines for the same use
- Other nitrate vasodilators
- the pharmacologic class, with prices and generics
- Isosorbide dinitrate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other