Prescription medicine
Enalapril Brand names: Vasotec, Epaned
Enalapril (Vasotec) is a prescription medicine with an FDA approval on record since 1985. FDA's NDC Directory lists it from 28 generic labelers, and pharmacies paid $0.0664 per enalapril maleate 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the enalapril FDA label on DailyMed (effective January 23, 2026, Bausch Health US LLC); the NDA 18998 record on Drugs@FDA; every enalapril label on DailyMed.
Highlights of the record
FDA label of January 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue VASOTEC ® as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS, Fetal Toxicity ).
Used for
From the label: indications and usageHypertension VASOTEC is indicated for the treatment of hypertension.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
- 1 mg/ml
Tablet; solution.
On the market
- Earliest approval on file
- December 24, 1985 Vasotec, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first August 22, 2000; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 32 of which 28 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- March 25, 2036 Epaned oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0664 per tablet Enalapril maleate 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 17 since 2012 0 Class I among all firms' recalls; latest April 23, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 60,702 through July 30, 2026
What is enalapril used for?
From the label: indications and usageHypertension VASOTEC is indicated for the treatment of hypertension. VASOTEC is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of VASOTEC and thiazides are approximately additive. Heart Failure VASOTEC is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients VASOTEC improves symptoms, increases survival, and decreases the frequency of hospitalization (see CLINICAL PHARMACOLOGY , Heart Failure, Mortality Trials for details and limitations of survival trials). […]
Conditions named in the indications of enalapril's FDA labels, with every medicine labeled for each:
From other enalapril labelsHigh blood pressure: INDICATIONS AND USAGE Hypertension VASOTEC is indicated for the treatment of hypertension.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Vasotec), Bausch Health US LLC, effective January 23, 2026 (SPL set 39631f1f-5d19-43c1-b504-bf56d991ed97), via openFDA; the full label on DailyMed
Is there a generic for enalapril (Vasotec)?
The FDA approved the first generic enalapril on August 22, 2000. 23 generic applications are approved; 13 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 enalapril from 28 labelers under a generic (ANDA) application and from 3 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 Vasotec tablets; a patent listed only for Epaned oral solution runs to March 25, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1985 earliest approval on file
- 2000 first generic approved
- 2036 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 enalapril (Vasotec)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0664 per Enalapril maleate 10 mg tablet, down 12% from $0.0753 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.
- Enalapril maleate 10 mg tablet (generic)
- Epaned 1 mg/mL oral solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Enalapril 1 mg/mL oral solution | Generic | $0.795 per mL | n/a | -30% |
| Enalapril maleate 10 mg tablet | Generic | $0.0664 per tablet | $1.99 | -12% |
| Enalapril maleate 2.5 mg tablet | Generic | $0.0625 per tablet | $1.88 | -15% |
| Enalapril maleate 20 mg tablet | Generic | $0.0953 per tablet | $2.86 | -11% |
| Enalapril maleate 5 mg tablet | Generic | $0.0724 per tablet | $2.17 | -12% |
| Epaned 1 mg/mL oral solution | Brand | $4.48 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has enalapril been recalled?
The FDA's Enforcement Report lists 19 recalls naming enalapril since 2012: 0 Class I (the most serious), 6 Class II, 13 Class III; 5 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of enalapril 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 |
|---|---|---|---|
| April 23, 2026 | Class II | JB Chemicals and Pharmaceuticals Ltd | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test |
| March 16, 2022 | Class II | Golden State Medical Supply Inc. | CGMP Deviations |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| June 27, 2018 | Class III | Aidarex Pharmaceuticals LLC | Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability. |
| June 26, 2018 | Class III | MAJOR PHARMACEUTICALS | Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to … |
| June 25, 2018 | Class III | AMERICAN HEALTH PACKAGING | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant |
| June 19, 2018 | Class III | Wockhardt Limited | Failed Impurities/Degradation Specifications |
| September 5, 2017 | Class III | Aidarex Pharmaceuticals LLC not a listed maker | Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the enalapril label say about other medicines?
The enalapril label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name enalapril. 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 |
|---|---|---|
| Aliskiren | contraindications | Do not coadminister aliskiren with VASOTEC in patients with diabetes (see PRECAUTIONS , Drug Interactions ). |
| Amiloride | drug interactions | Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. |
| Captopril | warnings | Neutropenia/Agranulocytosis Another angiotensin-converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment, especially if they also have a collagen vascular disease. |
| Digoxin | drug interactions | Other Cardiovascular Agents VASOTEC has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions. |
| Epinephrine | warnings | Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided (see ADVERSE REACTIONS ). |
| Everolimus | drug interactions | … Inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS , Head and Neck Angioedema ). |
| Hydralazine | drug interactions | Other Cardiovascular Agents VASOTEC has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions. |
| Indomethacin | drug interactions | In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving VASOTEC. |
| Lithium | drug interactions | Lithium Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. |
| Methyldopa | drug interactions | Other Cardiovascular Agents VASOTEC has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions. |
| Prazosin | drug interactions | Other Cardiovascular Agents VASOTEC has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions. |
| Sacubitril and valsartan | contraindications | Do not administer VASOTEC within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS , Head and Neck Angioedema ). |
| Sirolimus | drug interactions | … of Rapamycin) Inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS , Head and Neck Angioedema ). |
| Spironolactone | drug interactions | Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. |
Every other medicine the enalapril label names
| Medicine named | Section | What the label says |
|---|---|---|
| Sulindac | drug interactions | In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving VASOTEC. |
| Temsirolimus | drug interactions | … receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS , Head and Neck Angioedema ). |
| Triamterene | drug interactions | Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. |
Other labels that name enalapril
Source: FDA drug label (Vasotec), Bausch Health US LLC, effective January 23, 2026 (SPL set 39631f1f-5d19-43c1-b504-bf56d991ed97), via openFDA; the full label on DailyMed
What do FAERS reports show for enalapril?
The FDA Adverse Event Reporting System holds 60,702 reports that list enalapril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,506 are coded as a death and 29,024 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 enalapril?
78 other medicines are given the same way (oral) and in the same FDA class as enalapril or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. 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 |
|---|---|---|---|---|
| Lisinopril | High blood pressure, Heart failure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and lisinopril | High blood pressure | 27 labelers | $0.0293 per tablet 10-12.5 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Ramipril | High blood pressure | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Captopril | High blood pressure, Heart failure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Quinapril | High blood pressure, Heart failure | 9 labelers | n/a | In shortage |
| Fosinopril | High blood pressure, Heart failure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does enalapril compare with medicines for the same use?
21 side-by-side pages set enalapril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to enalapril
- 78 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Enalapril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other