Prescription medicine
Benazepril Brand names: Lotensin
Benazepril (Lotensin) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $0.0789 per benazepril HCl 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the benazepril FDA label on DailyMed (effective September 30, 2025, Validus Pharmaceuticals LLC); the NDA 19851 record on Drugs@FDA; every benazepril label on DailyMed.
Highlights of the record
FDA label of September 30, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinueLotensin as soon as possible. Drugs thatactdirectlyon the renin-angiotensin system can causeinjury and death to the developing fetus [see Warnings and Precautions (5.1) ]. WARNING-FETAL TOXICITY See full prescribinginformation forcomplete boxed warning. When pregnancyis detected, discontinue Lotensin as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageINDICATIONS AND USAGE Lotensin ® is indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 40 mg
Coated tablet; tablet; film-coated tablet.
On the market
- Earliest approval on file
- June 25, 1991 Lotensin, Validus Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first February 11, 2004; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 21 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0789 per tablet Benazepril HCl 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest September 24, 2019; 2 more by firms not listed as its makers
- FAERS reports
- 7,283 through July 30, 2026
What is benazepril used for?
From the label: indications and usageINDICATIONS AND USAGE Lotensin ® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. […]
Conditions named in the indications of benazepril's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Lotensin), Validus Pharmaceuticals LLC, effective September 30, 2025 (SPL set 2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e), via openFDA; the full label on DailyMed
Is there a generic for benazepril (Lotensin)?
The FDA approved the first generic benazepril on February 11, 2004. 12 generic applications are approved; 10 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 benazepril from 21 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.
- 1991 earliest approval on file
- 2004 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 benazepril (Lotensin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0789 per Benazepril HCl 20 mg tablet, up 6% from $0.0746 on October 8, 2025. 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.
- Benazepril HCl 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Benazepril HCl 10 mg tablet | Generic | $0.0651 per tablet | $1.95 | +8% |
| Benazepril HCl 20 mg tablet | Generic | $0.0789 per tablet | $2.37 | +6% |
| Benazepril HCl 40 mg tablet | Generic | $0.101 per tablet | $3.03 | +6% |
| Benazepril HCl 5 mg tablet | Generic | $0.0484 per tablet | $1.45 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has benazepril been recalled?
The FDA's Enforcement Report lists 3 recalls naming benazepril since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of benazepril 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 |
|---|---|---|---|
| September 24, 2019 | Class III | Amneal Pharmaceuticals, Inc. | Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 5 mg may be potentially mislabeled as ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: AD52993_34, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; BENAZEPRIL HCL Tablet, 40 mg may be potentially mislabeled as NEFAZODONE HCL, Tablet, 200 mg, NDC 00093102506, Pedigree: AD46414_44, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the benazepril label say about other medicines?
The benazepril label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name benazepril. 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 angiotensin receptor blockers, ACE inhibitors, including Lotensin in patients with diabetes [see Drug Interactions (7.4) ]. |
| Amiloride | drug interactions | Hyperkalemia Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. |
| Everolimus | drug interactions | Target of Rapamycin (mTOR) Inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. |
| Lithium | drug interactions | Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) Lithium: Symptoms of lithium toxicity ( 7.6 ) Neprilysin Inhibitor: |
| Sacubitril and valsartan | contraindications | Do not administer Lotensin within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2) ]. |
| Sirolimus | drug interactions | Target of Rapamycin (mTOR) Inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. |
| Spironolactone | drug interactions | Hyperkalemia Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. |
| Temsirolimus | drug interactions | Target of Rapamycin (mTOR) Inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. |
| Triamterene | drug interactions | Hyperkalemia Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. |
Source: FDA drug label (Lotensin), Validus Pharmaceuticals LLC, effective September 30, 2025 (SPL set 2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e), via openFDA; the full label on DailyMed
What do FAERS reports show for benazepril?
The FDA Adverse Event Reporting System holds 7,283 reports that list benazepril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 579 are coded as a death and 2,485 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 benazepril?
70 other medicines are given the same way (oral) and in the same FDA class as benazepril 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 | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Enalapril | High blood pressure | 29 labelers | $0.0664 per tablet 10 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 |
| Ramipril | High blood pressure | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Captopril | High blood pressure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Quinapril | High blood pressure | 9 labelers | n/a | In shortage |
| Fosinopril | High blood pressure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
| Trandolapril | High blood pressure | 5 labelers | $0.157 per tablet 1 mg tablet | No current entry |
Every medicine labeled for the same conditions as benazepril
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does benazepril compare with medicines for the same use?
9 side-by-side pages set benazepril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to benazepril
- 70 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Benazepril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other