Quick answers
- What is Isosorbide dinitrate used for?
- The FDA-approved label (Isosorbide Dinitrate, Oceanside Pharmaceuticals, March 2, 2020) says: “Isosorbide 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isosorbide dinitrate have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Isosorbide dinitrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isosorbide dinitrate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 2, 2018 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Isosorbide dinitrate?
- 18 companies list prescription products of Isosorbide dinitrate in the FDA NDC Directory, including Zydus Lifesciences Limited, Par Health USA, LLC and Zydus Pharmaceuticals USA Inc..
What Isosorbide dinitrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Isosorbide 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.
— FDA label: Isosorbide Dinitrate, Oceanside Pharmaceuticals, effective March 2, 2020. Read the full label on DailyMed →
The FDA has 21 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 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 55 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 dinitrate 10 mg tablet | Generic | $0.1688 per tablet |
| isosorbide dinitrate 20 mg tablet | Generic | $0.1852 per tablet |
| isosorbide dinitrate 30 mg tablet | Generic | $0.2626 per tablet |
| isosorbide dinitrate 40 mg tablet | Generic | $3.36 per tablet |
| isosorbide dinitrate 5 mg tablet | Generic | $0.1601 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.
- Zydus Lifesciences Limited5 products
- Par Health USA, LLC5 products
- Zydus Pharmaceuticals USA Inc.5 products
- Advagen Pharma Ltd5 products
- BluePoint Laboratories4 products
- NorthStar Rx LLC4 products
- Golden State Medical Supply, Inc.3 products
- Sandoz Inc3 products
- Hikma Pharmaceuticals USA Inc.3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- AvPAK3 products
- Major Pharmaceuticals2 products
- Oceanside Pharmaceuticals2 products
- American Health Packaging2 products
- Proficient Rx LP2 products
- Cardinal Health 107, LLC2 products
- Bryant Ranch Prepack1 product
- Remedyrepack 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 |
|---|---|---|---|
| NDA012093 ISORDIL | Bausch | November 9, 1959 | 8, latest January 14, 2015 2015: Labeling · 2014: Manufacturing (CMC) · 2001: Labeling |
Generic approvals (13)
- ANDA086923Ph Health · March 12, 1987
- ANDA086925Ph Health · March 12, 1987
- ANDA087946Ph Health · March 12, 1987
- ANDA087537Ph Health · October 2, 1987
- ANDA088088Hikma · November 2, 1987
- ANDA086221Sandoz · January 7, 1988
- ANDA086223Sandoz · January 7, 1988
- ANDA089367Sandoz · April 7, 1988
- ANDA213057Zydus Lifesciences · November 20, 2019
- ANDA211290Ph Health · November 23, 2021
- ANDA215723Rubicon Research · July 8, 2022
- ANDA086066—
- ANDA086067—
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 2, 2018 · Class II · Terminated · D-0258-2019
Cross Contamination with Other Products
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01 — Sandoz Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Isosorbide Dinitrate, Oceanside Pharmaceuticals, effective March 2, 2020; 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 →