Prescription medicine
Nitroglycerin Brand names: Nitrostat, Nitro-Dur, Nitrolingual, Rectiv, Nitro-Bid; first approved as Tridil
Nitroglycerin (Nitrostat) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $0.127 per tablet (Nitroglycerin 0.4 mg tablet sl) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1.24 per gram (Nitro-bid 2% ointment).
- Generic listed
- A presentation discontinued
Check it at the source: the nitroglycerin FDA label on DailyMed (effective February 15, 2023, Viatris Specialty LLC); the NDA 18537 record on Drugs@FDA; every nitroglycerin label on DailyMed.
Highlights of the record
FDA label of February 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageNITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Forms and strengths
- 0.3 mg
- 0.4 mg
- 0.6 mg
- 20 mg
- 40 mg
- 60 mg
- 80 mg
- 120 mg
- 160 mg
- 0.1 mg/h
- 0.2 mg/h
- 0.4 mg/h
Tablet; patch; ointment; spray; injection.
On the market
- Earliest approval on file
- September 30, 1981 Tridil, Hospira; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 40 first May 28, 1981; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 39 of which 31 under generic applications, 10 under brand applications, repackagers included
- Last listed patent
- March 11, 2032 Gonitro powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.127 per tablet Nitroglycerin 0.4 mg tablet sl
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 13 since 2013 4 Class I among all firms' recalls; latest July 24, 2026
- FAERS reports
- 53,311 through July 30, 2026
What is nitroglycerin used for?
From the label: indications and usageNITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NITROSTAT is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Conditions named in the indications of nitroglycerin's FDA labels, with every medicine labeled for each:
From other nitroglycerin labelsHigh blood pressure, Heart failure and Heart attack and coronary artery disease: INDICATIONS AND USAGE Nitroglycerin Injection is indicated for treatment of peri-operative hypertension; for control of congestive heart failure in the setting of acute myocardial infarction; …
FDA pharmacologic class: Nitrate Vasodilator.
Source: FDA drug label (Nitrostat), Viatris Specialty LLC, effective February 15, 2023 (SPL set 9a52da75-d0af-4237-96c0-0b12adfa8636), via openFDA; the full label on DailyMed
What does the patient leaflet for nitroglycerin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking NITROSTAT?Do not breastfeed. It is not known if NITROSTAT will pass through your milk. • Do not consume alcohol while taking NITROSTAT , as this can lower your blood pressure. • Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.
Source: FDA drug label (Nitrostat), Viatris Specialty LLC, effective February 15, 2023 (SPL set 9a52da75-d0af-4237-96c0-0b12adfa8636), via openFDA; the full label on DailyMed
Is there a generic for nitroglycerin (Nitrostat)?
The FDA approved the first generic nitroglycerin on May 28, 1981. 40 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists nitroglycerin from 31 labelers under a generic (ANDA) application and from 10 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Nitrostat tablets; a patent listed only for Gonitro powder runs to March 11, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1981 earliest approval on file
- 1981 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nitroglycerin (Nitrostat)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.127 per tablet (Nitroglycerin 0.4 mg tablet sl), down 24% from $0.168 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.
- Nitroglycerin 0.4 mg tablet sl (generic)
- Nitro-bid 2% ointment (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nitroglycerin 0.1 mg/hr patch | Generic | $0.493 per patch | n/a | +3% |
| Nitroglycerin 0.2 mg/hr patch | Generic | $0.590 per patch | n/a | +3% |
| Nitroglycerin 0.3 mg tablet sl | Generic | $0.0631 per tablet | $1.89 | -16% |
| Nitroglycerin 0.4 mg tablet sl | Generic | $0.127 per tablet | $3.82 | -24% |
| Nitroglycerin 0.4 mg/hr patch | Generic | $0.721 per patch | n/a | +3% |
| Nitroglycerin 0.4% ointment | Generic | $8.31 per gram | n/a | -38% |
| Nitroglycerin 0.6 mg tablet sl | Generic | $0.0843 per tablet | $2.53 | +15% |
| Nitroglycerin 0.6 mg/hr patch | Generic | $0.963 per patch | n/a | +8% |
| Nitroglycerin 400 mcg spray | Generic | $23.52 per gram | n/a | -8% |
| Nitro-bid 2% ointment | Brand | $1.24 per gram | n/a | +0.2% |
| Nitro-dur 0.3 mg/hr patch | Brand | $50.50 per patch many times the lowest per-tablet cost; NADAC records the price, not why | n/a | no change |
| Rectiv 0.4% ointment | Brand | $20.59 per gram | n/a | +0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is nitroglycerin in shortage?
No nitroglycerin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated April 14, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Rectiv, Ointment, 0.4% (NDC 58914-301-80) | AbbVie Inc. | To Be Discontinued | April 14, 2026 |
Every nitroglycerin presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has nitroglycerin been recalled?
The FDA's Enforcement Report lists 13 recalls naming nitroglycerin since 2013: 4 Class I (the most serious), 9 Class II, 0 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 24, 2026 | Class II | American Regent, Inc. | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde |
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| December 27, 2021 | Class II | Padagis US LLC | Defective Delivery System |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| June 9, 2017 | Class I | Advanced Pharma Inc. | Subpotent Drug: found to be below the specification for labeled assay. |
| June 9, 2017 | Class II | Advanced Pharma Inc. | Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system. |
| November 18, 2013 | Class I | Baxter Healthcare Corp. | Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nitroglycerin label say about other medicines?
The nitroglycerin label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 23 other medicines name nitroglycerin. 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 |
|---|---|---|
| Aspirin | drug interactions | Drug interactions Aspirin Coadministration of nitroglycerin with high dose aspirin (1000 mg) results in increased exposure to nitroglycerin. |
| Avanafil | contraindications | Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. |
| Dihydroergotamine | drug interactions | Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. |
| Ergotamine | drug interactions | DRUG INTERACTIONS Ergotamine: increased bioavailability of ergotamine. |
| Heparin | drug interactions | Nitroglycerin at higher dosages may interfere with the anticoagulant effect of heparin. |
| Riociguat | contraindications | Do not use NITROSTAT in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. |
| Sildenafil | contraindications | Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. |
| Tadalafil | contraindications | Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. |
| Vardenafil | contraindications | Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. |
Other labels that name nitroglycerin
Source: FDA drug label (Nitrostat), Viatris Specialty LLC, effective February 15, 2023 (SPL set 9a52da75-d0af-4237-96c0-0b12adfa8636), via openFDA; the full label on DailyMed
What do FAERS reports show for nitroglycerin?
The FDA Adverse Event Reporting System holds 53,311 reports that list nitroglycerin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7,013 are coded as a death and 24,315 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 next?
- Alternatives to nitroglycerin
- medicines labeled for the same conditions
- Other nitrate vasodilators
- the pharmacologic class, with prices and generics
- Nitroglycerin side effects
- the label's list beside FAERS reports
- Nitroglycerin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other