Prescription medicine
Amlodipine and benazepril First approved as Lotrel
Amlodipine and benazepril (Lotrel) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.114 per unit (Amlodipine-benazepril 10-20 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and benazepril FDA label on DailyMed (effective October 3, 2025, Lupin Pharmaceuticals, Inc.); the NDA 20364 record on Drugs@FDA; every amlodipine and benazepril label on DailyMed.
Highlights of the record
FDA label of October 3, 2025; 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 amlodipine and benazepril hydrochloride capsules as soon as possible ( 5.5 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus ( 5.5 ) WARNING: FETAL TOXICITY When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible ( 5.5 ). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus
Used for
From the label: indications and usageAmlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor.
Forms and strengths
- 2.5 mg / 10 mg
- 5 mg / 20 mg
- 5 mg / 10 mg
- 5 mg / 40 mg
- 10 mg / 20 mg
- 10 mg / 40 mg
- 20 mg / 5 mg
Capsule.
On the market
- Earliest approval on file
- March 3, 1995 Lotrel, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first May 18, 2007; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 16 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.114 per unit Amlodipine-benazepril 10-20 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest July 2, 2025
- FAERS reports
- 643 through July 30, 2026
What is amlodipine and benazepril used for?
From the label: indications and usageAmlodipine and benazepril hydrochloride capsule, is a combination capsule of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1 ). 1.1 Hypertension Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.
Conditions named in the indications of amlodipine and benazepril's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor, Calcium Channel Blocker and Dihydropyridine Calcium Channel Blocker.
Source: FDA drug label (Amlodipine Besylate and Benazepril Hydrochloride), Lupin Pharmaceuticals, Inc., effective October 3, 2025 (SPL set 968c611b-43a7-40f0-9ed3-aa67ee88364b), via openFDA; the full label on DailyMed
What does the patient leaflet for amlodipine and benazepril say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about amlodipine and benazepril hydrochloride capsules?Amlodipine and benazepril hydrochloride capsules can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking amlodipine and benazepril hydrochloride capsules, tell your doctor right away.
Source: FDA drug label (Amlodipine Besylate and Benazepril Hydrochloride), Lupin Pharmaceuticals, Inc., effective October 3, 2025 (SPL set 968c611b-43a7-40f0-9ed3-aa67ee88364b), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and benazepril (Lotrel)?
The FDA approved the first generic amlodipine and benazepril on May 18, 2007. 12 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists amlodipine and benazepril from 16 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1995 earliest approval on file
- 2007 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 amlodipine and benazepril (Lotrel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.114 per unit (Amlodipine-benazepril 10-20 mg), down 8% from $0.123 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.
- Amlodipine-benazepril 5-10 mg (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amlodipine-benazepril 10-20 mg | Generic | $0.114 per unit | n/a | -8% |
| Amlodipine-benazepril 10-40 mg | Generic | $0.152 per unit | n/a | +3% |
| Amlodipine-benazepril 2.5-10 | Generic | $0.0956 per unit | n/a | -4% |
| Amlodipine-benazepril 5-10 mg | Generic | $0.099 per unit | n/a | +0.3% |
| Amlodipine-benazepril 5-20 mg | Generic | $0.103 per unit | n/a | -4% |
| Amlodipine-benazepril 5-40 mg | Generic | $0.144 per unit | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amlodipine and benazepril been recalled?
The FDA's Enforcement Report lists 8 recalls naming amlodipine and benazepril since 2012: 0 Class I (the most serious), 8 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 2, 2025 | Class II | Lupin Pharmaceuticals Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 |
| September 13, 2013 | Class II | Mylan Pharmaceuticals Inc. | CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. |
| April 9, 2012 | Class II | Dr. Reddy's Laboratories, Inc. | Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amlodipine and benazepril label say about other medicines?
The amlodipine and benazepril label names 11 other medicines in its interaction, contraindication or warning sections. 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 | CONTRAINDICATIONS Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride, in patients with diabetes. ( 4 ) Amlodipine and benazepril hydrochloride is contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to amlodipine. … |
| Amiloride | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. |
| Epinephrine | warnings and precautions | When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., administer subcutaneous epinephrine injection 1:1000 (0.3 to 0.5 mL), promptly [ see Adverse Reactions ( 6 ) ]. |
| Everolimus | drug interactions | Mammalian Target of Rapamycin (mTOR) Inhibitors: The risk of angioedema may be increased in patients receiving coadministration of ACE inhibitors and mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus). |
| Lithium | drug interactions | Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. |
| Sacubitril and valsartan | contraindications | Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan. ( 5.1 ) Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine and benazepril hydrochloride in patients … |
| Simvastatin | drug interactions | Risk of renal dysfunction, loss of antihypertensive effect. ( 7.1 ) Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.1 ) mTOR inhibitors: increased risk of angioedema. ( 7.1 ) Dual inhibition of the renin-angiotensin system (RAS): |
| Sirolimus | drug interactions | Mammalian Target of Rapamycin (mTOR) Inhibitors: The risk of angioedema may be increased in patients receiving coadministration of ACE inhibitors and mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus). |
| Spironolactone | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. |
| Temsirolimus | drug interactions | Mammalian Target of Rapamycin (mTOR) Inhibitors: The risk of angioedema may be increased in patients receiving coadministration of ACE inhibitors and mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus). |
| Triamterene | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) or potassium supplements can increase the risk of hyperkalemia. |
Source: FDA drug label (Amlodipine Besylate and Benazepril Hydrochloride), Lupin Pharmaceuticals, Inc., effective October 3, 2025 (SPL set 968c611b-43a7-40f0-9ed3-aa67ee88364b), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and benazepril?
The FDA Adverse Event Reporting System holds 643 reports that list amlodipine and benazepril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 166 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 amlodipine and benazepril?
62 other medicines are given the same way (oral) and in the same FDA class as amlodipine and 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 |
|---|---|---|---|---|
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Lisinopril | High blood pressure | 36 labelers | $0.0254 per tablet 20 mg tablet | No current entry |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 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 |
| Verapamil | High blood pressure | 24 labelers | $0.191 per tablet 180 mg tablet | A presentation being discontinued |
| Ramipril | High blood pressure | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Felodipine | High blood pressure | 14 labelers | $0.123 per tablet 5 mg tablet | No current entry |
Every medicine labeled for the same conditions as amlodipine and benazepril
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to amlodipine and benazepril
- 62 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Amlodipine and benazepril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other