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Benazepril Hydrochloride and Hydrochlorothiazide
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Benazepril Hydrochloride | 10 mg/1 | 898356 | View |
| Benazepril Hydrochloride | 20 mg/1 | 898356 | View |
| Benazepril Hydrochloride | 5 mg/1 | 898356 | View |
| Hydrochlorothiazide | 12.5 mg/1 | 999967 | View |
| Hydrochlorothiazide | 25 mg/1 | 999967 | View |
| Hydrochlorothiazide | 6.25 mg/1 | 999967 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Angiotensin Converting Enzyme Inhibitor [EPC] | EPC | All 34 members |
| Angiotensin-converting Enzyme Inhibitors [MoA] | MoA | All 34 members |
| Decreased Blood Pressure [PE] | PE | All 21 members |
| Increased Diuresis [PE] | PE | All 59 members |
| Thiazide Diuretic [EPC] | EPC | All 47 members |
| Thiazides [CS] | CS | All 47 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076631-001 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | TABLET | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | Prescription | AB | ||
| 076631-002 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | TABLET | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | Prescription | AB | ||
| 076631-003 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | TABLET | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | Prescription | AB | ||
| 076631-004 | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | TABLET | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | Prescription | AB | RS |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 37 | Labeling | Approved | November 3, 2020 | Standard |
| Supplement | 34 | Labeling | Approved | November 3, 2020 | Standard |
| Supplement | 32 | Labeling | Approved | August 16, 2018 | Standard |
| Supplement | 29 | Labeling | Approved | March 24, 2016 | Standard |
| Supplement | 27 | Labeling | Approved | June 30, 2015 | Standard |
| Supplement | 19 | Labeling | Approved | September 23, 2014 | Standard |
| Supplement | 16 | Labeling | Approved | September 23, 2014 | — |
| Supplement | 15 | Labeling | Approved | August 2, 2011 | — |
| Supplement | 14 | Labeling | Approved | July 28, 2011 | — |
| Supplement | 13 | Labeling | Approved | March 17, 2010 | — |
| Supplement | 11 | Labeling | Approved | December 28, 2009 | — |
| Supplement | 9 | Labeling | Approved | August 31, 2009 | — |
| Supplement | 7 | Labeling | Approved | September 25, 2007 | — |
| Original application | 1 | Approved | February 11, 2004 | — |
Review documents
- 0 · Original application · February 12, 2004
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250614). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride and hydrochlorothiazide 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).
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Benazepril hydrochloride and hydrochlorothiazide tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ).
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20/25 mg. Switch Therapy A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may be switched to combination therapy with benazepril hydrochloride and hydrochlorothiazide tablets. The usual recommended starting dose is 10/12.5 mg once daily to control blood pressure. Replacement Therapy The combination may be substituted for the titrated individual components.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Benazepril hydrochloride and hydrochlorothiazide is contraindicated in patients who are anuric. Benazepril hydrochloride and hydrochlorothiazide is also contraindicated in patients who are hypersensitive to benazepril, to any other ACE inhibitor, to hydrochlorothiazide, or to other sulfonamide-derived drugs. Hypersensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma. Benazepril hydrochloride and hydrochlorothiazide is also contraindicated in patients with a history of angioedema with or without previous ACE inhibitor treatment. Benazepril hydrochloride and hydrochlorothiazide is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer benazepril hydrochloride and hydrochlorothiazide within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS ). Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including benazepril hydrochloride and hydrochlorothiazide in patients with diabetes.
Warnings
openFDA Drug LabelingWARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including benazepril) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors. In U.S. clinical trials, symptoms consistent with angioedema were seen in none of the subjects who received placebo and in about 0.5% of the subjects who received benazepril. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with benazepril hydrochloride and hydrochlorothiazide should be discontinued and appropriate therapy instituted immediately. When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine injection 1:1000 (0.3 to 0.5 mL) should be promptly administered (see PRECAUTIONS and ADVERSE REACTIONS ). Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS ). Intestinal Angioedema Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. Anaphylactoid Reactions During Membrane Exposure Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. Hypersensitivity reactions to hydrochlorothiazide are more likely in patients with allergy and asthma. Hypotension Benazepril hydrochloride and hydrochlorothiazide can cause symptomatic hypotension. Like other ACE inhibitors, benazepril has been only rarely associated with hypotension in uncomplicated hypertensive patients. Symptomatic hypotension is most likely to occur in patients who have been volume and/or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting. Volume and/or salt depletion should be corrected before initiating therapy with benazepril hydrochloride and hydrochlorothiazide. Benazepril hydrochloride and hydrochlorothiazide should be used cautiously in patients receiving concomitant therapy with other antihypertensives. The thiazide component of benazepril hydrochloride and hydrochlorothiazide may potentiate the action of other antihypertensive drugs, especially ganglionic or peripheral adrenergic-blocking drugs. The antihypertensive effects of the thiazide component may also be enhanced in the postsympathectomy patient. In patients with congestive heart failure, with or without assoc …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Benazepril hydrochloride and hydrochlorothiazide has been evaluated for safety in over 2500 patients with hypertension; over 500 of these patients were treated for at least 6 months, and over 200 were treated for more than 1 year. The reported side effects were generally mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects was required in approximately 7% of U.S. patients treated with benazepril hydrochloride and hydrochlorothiazide and in 4% of patients treated with placebo. The most common reasons for discontinuation of therapy with benazepril hydrochloride and hydrochlorothiazide in U.S. studies were cough (1.0%; see PRECAUTIONS ), “dizziness” (1.0%), headache (0.6%), and fatigue (0.6%). The side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in more than 1% of patients treated with benazepril hydrochloride and hydrochlorothiazide are shown in the table below. Reactions Possibly or Probably Drug Related Patients in U.S. Placebo-Controlled Studies Benazepril Hydrochloride and Hydrochlorothiazide N=665 Placebo N=235 N % N % “Dizziness” 41 6.3 8 3.4 Fatigue 34 5.2 6 2.6 Postural Dizziness 23 3.5 1 0.4 Headache 20 3.1 10 4.3 Cough 14 2.1 3 1.3 Hypertonia 10 1.5 3 1.3 Vertigo 10 1.5 2 0.9 Nausea 9 1.4 2 0.9 Impotence 8 1.2 0 0.0 Somnolence 8 1.2 1 0.4 Other side effects considered possibly or probably related to study drug that occurred in U.S. placebo-controlled trials in 0.3% to 1.0% of patients treated with benazepril hydrochloride and hydrochlorothiazide were the following: Cardiovascular Palpitations, flushing. Gastrointestinal Vomiting, diarrhea, dyspepsia, anorexia, and constipation. Neurologic and Psychiatric Insomnia, nervousness, paresthesia, libido decrease, dry mouth, taste perversion, and tinnitus. Dermatologic Rash and sweating. Other Urinary frequency, arthralgia, myalgia, asthenia, and pain (including chest pain and abdominal pain). Other adverse experiences reported in 0.3% or more of benazepril hydrochloride and hydrochlorothiazide patients in U.S. controlled clinical trials, and rarer events seen in post-marketing experience, were the following; asterisked entries occurred in more than 1% of patients (in some, a causal relationship to benazepril hydrochloride and hydrochlorothiazide is uncertain): Cardiovascular Syncope, peripheral vascular disorder, and tachycardia. Body as a Whole Infection, back pain*, flu syndrome*, fever, chills, and neck pain. Dermatologic Photosensitivity and pruritus. Gastrointestinal Gastroenteritis, flatulence, and tooth disorder. Neurologic and Psychiatric Hypesthesia, abnormal vision, abnormal dreams, and retinal disorder. Respiratory Upper respiratory infection*, epistaxis, bronchitis, rhinitis*, sinusitis*, and voice alteration. Other Conjunctivitis, arthritis, urinary tract infection, alopecia, and urinary frequency*. Post-Marketing Experience The following adverse reactions have been identified during post-approval use of either benazepril or hydrochlorothiazide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Non-melanoma Skin Cancer Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year. Benazepril Stevens-Johnson syndrome, pancreatitis, hemolytic anemia, pemphigus, and thrombocytopenia, …
Description
openFDA Drug LabelingDESCRIPTION Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (>100 mg/mL) in water, in ethanol, and in methanol. Benazepril hydrochloride's chemical name is 3-[[1-(ethoxycarbonyl)-3-phenyl-(1S)-propyl]amino]-2,3,4,5- tetrahydro-2-oxo-1 H -1-(3S)-benzazepine-1-acetic acid monohydrochloride; its structural formula is: Its molecular formula is C 24 H 28 N 2 O 5 •HCl, and its molecular weight is 460.96. Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl angiotensin-converting enzyme inhibitor. Benazepril is converted to benazeprilat by hepatic cleavage of the ester group. Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide's chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide; its structural formula is: Its molecular formula is C 7 H 8 ClN 3 O 4 S 2, and its molecular weight is 297.73. Hydrochlorothiazide is a thiazide diuretic. The tablets are a combination of benazepril hydrochloride, USP and hydrochlorothiazide, USP. They are formulated for oral administration with a combination of 5 mg, 10 mg, or 20 mg of benazepril hydrochloride and 6.25 mg, 12.5 mg, or 25 mg of hydrochlorothiazide, USP. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydrogenated castor oil, lactose monohydrate, poloxamer, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and zinc stearate. The 5 mg/6.25 mg tablets also contain polyvinyl alcohol - part hydrolyzed and talc. The 10 mg/12.5 mg tablets also contain FD&C red No. 40, FD&C yellow No. 6, polyvinyl alcohol and talc. The 20 mg/12.5 mg tablets also contain FD&C blue No. 2, FD&C red No. 40, hypromellose and polysorbate. The 20 mg/25 mg tablets also contain FD&C red No. 40, hypromellose and polysorbate. This product meets USP Dissolution Test 2. Chemical Structure 1 HCTZ Chemical Structure
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Benazepril Hydrochloride and Hydrochlorothiazide Tablets, USP for oral administration, are available as 5 mg/6.25 mg White to off-white, oblong, film-coated tablets, debossed " E 124" on one side and scored on the other side and supplied as: NDC 68462-576-01 bottles of 100 10 mg/12.5 mg Pink, oblong, film-coated tablets, debossed " E 204" on one side and scored on the other side and supplied as: NDC 68462-577-01 bottles of 100 20 mg/12.5 mg Lavender, oblong, film-coated tablets, debossed " E 211" on one side and scored on the other side and supplied as: NDC 68462-578-01 bottles of 100 20 mg/25 mg Maroon, oblong, film-coated tablets, debossed " E 277" on one side and scored on the other side and supplied as: NDC 68462-579-01 bottles of 100 Each strength is supplied in bottles that contain a desiccant. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Keep tightly closed. KEEP OUT OF THE REACH OF CHILDREN. Manufactured in India by: Sandoz Private Ltd. Distributed by: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Rev. April 2023 46326869
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: HYDROCHLOROTHIAZIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 68462-576-01 | 68462-576 | Glenmark Pharmaceuticals Inc., USA | 100 TABLET, FILM COATED in 1 BOTTLE (68462-576-01) | December 1, 2023 |
| 68462-577-01 | 68462-577 | Glenmark Pharmaceuticals Inc., USA | 100 TABLET, FILM COATED in 1 BOTTLE (68462-577-01) | December 1, 2023 |
| 68462-578-01 | 68462-578 | Glenmark Pharmaceuticals Inc., USA | 100 TABLET, FILM COATED in 1 BOTTLE (68462-578-01) | November 30, 2023 |
| 68462-579-01 | 68462-579 | Glenmark Pharmaceuticals Inc., USA | 100 TABLET, FILM COATED in 1 BOTTLE (68462-579-01) | December 1, 2023 |
| 0185-0211-01 | 0185-0211 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0211-01) | February 11, 2004 |
| 0185-0236-01 | 0185-0236 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0236-01) | March 17, 2015 |
| 0185-0277-01 | 0185-0277 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0277-01) | February 11, 2004 |
| 0185-0325-01 | 0185-0325 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0325-01) | April 4, 2014 |
| 68462-576 | 68462-576 | Glenmark Pharmaceuticals Inc., USA | — | March 17, 2015 |
| 68462-577 | 68462-577 | Glenmark Pharmaceuticals Inc., USA | — | April 4, 2014 |
| 68462-578 | 68462-578 | Glenmark Pharmaceuticals Inc., USA | — | February 11, 2004 |
| 68462-579 | 68462-579 | Glenmark Pharmaceuticals Inc., USA | — | February 11, 2004 |
| 0185-0211 | 0185-0211 | Sandoz Inc | — | February 11, 2004 |
| 0185-0236 | 0185-0236 | Sandoz Inc | — | March 17, 2015 |
| 0185-0277 | 0185-0277 | Sandoz Inc | — | February 11, 2004 |
| 0185-0325 | 0185-0325 | Sandoz Inc | — | April 4, 2014 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.