Quick answers
- What is Benazepril hydrochloride used for?
- The FDA-approved label (Lotensin, Validus Pharmaceuticals LLC, September 30, 2025) says: “1. INDICATIONS 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Benazepril hydrochloride have a boxed warning?
- Yes. The FDA label for Lotensin has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Benazepril hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Benazepril hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 24, 2019 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Benazepril hydrochloride?
- 20 companies list prescription products of Benazepril hydrochloride in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Northwind Health Company, LLC and Bryant Ranch Prepack.
What Benazepril hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS 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. …
— FDA label: Lotensin, Validus Pharmaceuticals LLC, effective September 30, 2025. Read the full label on DailyMed →
The FDA has 56 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.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
56 of 56 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, coated · Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 88 in the FDA NDC Directory |
| Brand names | Lotensin |
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 |
|---|---|---|
| benazepril hydrochloride 10 mg tablet | Generic | $0.0624 per tablet |
| benazepril hydrochloride 10 mg tablet, coated | Generic | $0.0624 per tablet |
| benazepril hydrochloride 20 mg tablet | Generic | $0.0780 per tablet |
| benazepril hydrochloride 20 mg tablet, coated | Generic | $0.0780 per tablet |
| benazepril hydrochloride 20 mg tablet, film coated | Generic | $0.0780 per tablet |
| benazepril hydrochloride 40 mg tablet | Generic | $0.0987 per tablet |
| benazepril hydrochloride 40 mg tablet, coated | Generic | $0.0987 per tablet |
| benazepril hydrochloride 40 mg tablet, film coated | Generic | $0.0987 per tablet |
| benazepril hydrochloride 5 mg tablet | Generic | $0.0476 per tablet |
| benazepril hydrochloride 5 mg tablet, coated | Generic | $0.0476 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.
- NuCare Pharmaceuticals, Inc.9 products
- Northwind Health Company, LLC7 products
- Bryant Ranch Prepack7 products
- Proficient Rx LP6 products
- A-S Medication Solutions6 products
- Preferred Pharmaceuticals Inc.5 products
- Aurobindo Pharma Limited5 products
- Solco Healthcare U.S., LLC4 products
- Chartwell RX, LLC4 products
- ANI Pharmaceuticals, Inc.4 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Amneal Pharmaceuticals LLC4 products
- AvPAK4 products
- Amneal Pharmaceuticals of New York LLC4 products
- Validus Pharmaceuticals LLC3 products
- PD-Rx Pharmaceuticals, Inc.3 products
- Cardinal Health 107, LLC2 products
- Remedyrepack Inc.2 products
- Direct_Rx1 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 |
|---|---|---|---|
| NDA019851 LOTENSIN | Validus Pharms | June 25, 1991 | 44, latest January 7, 2019 2019: Labeling · 2017: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (5)
- ANDA076118Prinston Inc · February 11, 2004
- ANDA076267Heritage Pharma · February 11, 2004
- ANDA076333Ani Pharms · February 11, 2004
- ANDA076820Amneal Pharms · February 3, 2006
- ANDA078212Aurobindo Pharma · May 22, 2008
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.
-
September 24, 2019 · Class III · Terminated · D-0134-2020
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10 — Amneal Pharmaceuticals, 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) — Lotensin, Validus Pharmaceuticals LLC, effective September 30, 2025; 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 →