Quick answers
- What is Benazepril hydrochloride and hydrochlorothiazide used for?
- The FDA-approved label (Lotensin HCT, Validus Pharmaceuticals LLC, February 24, 2026) says: “Lotensin HCT USP is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension ( see DOSAGE AND ADMINISTRATION ).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Benazepril hydrochloride and hydrochlorothiazide have a boxed warning?
- Yes. The FDA label for Lotensin HCT 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 and hydrochlorothiazide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Benazepril hydrochloride and hydrochlorothiazide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Benazepril hydrochloride and hydrochlorothiazide?
- 7 companies list prescription products of Benazepril hydrochloride and hydrochlorothiazide in the FDA NDC Directory, including ANI Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc., USA and Sandoz Inc.
What Benazepril hydrochloride and hydrochlorothiazide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Lotensin HCT USP is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension ( see DOSAGE AND ADMINISTRATION ).
— FDA label: Lotensin HCT, Validus Pharmaceuticals LLC, effective February 24, 2026. Read the full label on DailyMed →
The FDA has 7 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 →
7 of 7 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 21 in the FDA NDC Directory |
| Brand names | Lotensin Hct |
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 · hydrochlorothiazide 12.5 mg tablet | Generic | $0.2128 per tablet |
| benazepril hydrochloride 10 mg · hydrochlorothiazide 12.5 mg tablet, film coated | Generic | $0.2128 per tablet |
| benazepril hydrochloride 20 mg · hydrochlorothiazide 12.5 mg tablet | Generic | $0.2253 per tablet |
| benazepril hydrochloride 20 mg · hydrochlorothiazide 12.5 mg tablet, film coated | Generic | $0.2253 per tablet |
| benazepril hydrochloride 20 mg · hydrochlorothiazide 25 mg tablet | Generic | $0.2504 per tablet |
| benazepril hydrochloride 20 mg · hydrochlorothiazide 25 mg tablet, film coated | Generic | $0.2504 per tablet |
| benazepril hydrochloride 5 mg · hydrochlorothiazide 6.25 mg tablet | Generic | $0.5596 per tablet |
| benazepril hydrochloride 5 mg · hydrochlorothiazide 6.25 mg tablet, film coated | Generic | $0.5596 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.
- ANI Pharmaceuticals, Inc.4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Sandoz Inc4 products
- Advagen Pharma Ltd3 products
- Validus Pharmaceuticals LLC3 products
- Padagis US LLC2 products
- Bryant Ranch Prepack1 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 |
|---|---|---|---|
| NDA020033 LOTENSIN HCT | Validus Pharms | May 19, 1992 | 44, latest August 20, 2020 2020: Labeling · 2018: Labeling · 2017: Labeling |
Generic approvals (2)
- ANDA076342Ani Pharms · February 11, 2004
- ANDA076631Sandoz · February 11, 2004
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lotensin HCT, Validus Pharmaceuticals LLC, effective February 24, 2026; 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 →