What this pack is
LOTREL is the brand name in this record; amlodipine and benazepril hydrochloride is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
LOTRELGeneric nameamlodipine and benazepril hydrochloride
How this medicine works
The current label explains that amlodipine is a dihydropyridine calcium-channel blocker that inhibits transmembrane calcium influx into vascular smooth muscle and produces peripheral arterial vasodilation. Benazepril is converted to benazeprilat, which inhibits angiotensin-converting enzyme and reduces angiotensin II- and aldosterone-related effects. Combining both paths in one capsule does not let the site split or rebuild an individual's regimen from a blood-pressure number.
Read source: United States ↗Current regulatory record · reviewed 2026-08-29More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- LOTREL
- Generic name
- amlodipine and benazepril hydrochloride
- Dosage-form class
- Amlodipine/benazepril hydrochloride fixed two-ingredient oral capsules: the current public label lists 5/10, 5/20, 10/20 and 10/40 mg; each paired number states the two ingredients in one capsule
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
4 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)
Amlodipine 5 mg plus benazepril 10 mg per capsule; 100-capsule bottle
- Product code
- NDC 0078-0405-05
- Form and route
- LOTREL amlodipine/benazepril hydrochloride oral capsule · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- amlodipine
- 5 mglabelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction
- benazepril
- 10 mglabelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products
- Package
- 100 capsules per bottle
- Labelled appearance
- light-brown capsule with two white bands · capsule with two white bands; capsule form does not establish permission to open, divide or halve it · imprint Lotrel; code 2260Capsule appearance provides no tablet-splitting cue
United States label · Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)
Amlodipine 5 mg plus benazepril 20 mg per capsule; 100-capsule bottle
- Product code
- NDC 0078-0406-05
- Form and route
- LOTREL amlodipine/benazepril hydrochloride oral capsule · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- amlodipine
- 5 mglabelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction
- benazepril
- 20 mglabelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products
- Package
- 100 capsules per bottle
- Labelled appearance
- pink capsule with two white bands · capsule with two white bands; capsule form does not establish permission to open, divide or halve it · imprint Lotrel; code 2265Capsule appearance provides no tablet-splitting cue
United States label · Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)
Amlodipine 10 mg plus benazepril 20 mg per capsule; 100-capsule bottle
- Product code
- NDC 0078-0364-05
- Form and route
- LOTREL amlodipine/benazepril hydrochloride oral capsule · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- amlodipine
- 10 mglabelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction
- benazepril
- 20 mglabelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products
- Package
- 100 capsules per bottle
- Labelled appearance
- purple to amethyst capsule with two white bands · capsule with two white bands; capsule form does not establish permission to open, divide or halve it · imprint Lotrel; code 0364Capsule appearance provides no tablet-splitting cue
United States label · Current U.S. DailyMed public label (revised Aug 2023; verified 29 Aug 2026)
Amlodipine 10 mg plus benazepril 40 mg per capsule; 100-capsule bottle
- Product code
- NDC 0078-0379-05
- Form and route
- LOTREL amlodipine/benazepril hydrochloride oral capsule · oral (fixed two-ingredient product-identity field)
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-29; actual marketing, stock and availability are not established.
- amlodipine
- 10 mglabelled amount of the first ingredient per capsule; not an individual capsule count or conversion instruction
- benazepril
- 40 mglabelled amount of the second ingredient per capsule; not an instruction to add an ACE inhibitor or convert products
- Package
- 100 capsules per bottle
- Labelled appearance
- dark-blue capsule with two white bands · capsule with two white bands; capsule form does not establish permission to open, divide or halve it · imprint Lotrel; code 0379Capsule appearance provides no tablet-splitting cue
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
LOTREL label reading: one capsule already contains two blood-pressure ingredients; check duplicate amlodipine and ACE inhibitors first
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Each LOTREL capsule contains fixed amounts of amlodipine and benazepril. For example, 10/20 mg means 10 mg and 20 mg of the two ingredients in one capsule; it is not a half-capsule cue, a two-capsule cue, permission to open and divide it, or a sum that can be directly converted across products.
- Check the active ingredients on every pack. NORVASC is amlodipine alone, LOTENSIN is benazepril alone, and ZESTRIL, VASOTEC, ALTACE and CAPOTEN are also ACE inhibitors. If they appear with LOTREL, do not add, remove or alternate any pack yourself; a pharmacist or prescriber must review the complete prescriptions.
- ENTRESTO contains sacubitril/valsartan. The current LOTREL label contraindicates coadministration with a neprilysin inhibitor and states a 36-hour boundary around switching an ACE inhibitor. The site does not use this to arrange an individual's stopping or switching; contact the prescriber or pharmacist promptly for review.
- Swelling of the face, eyelids, lips, tongue or throat, or difficulty swallowing or breathing, may be angioedema and requires local emergency services immediately. Do not wait for a website assessment.
- Older or frail adults with marked dizziness, fainting, a fall, reduced urine or persistent vomiting or diarrhoea should contact the care team promptly; use local emergency services for severe or sudden symptoms or altered consciousness. Review blood pressure, kidney and liver function, potassium and the full medicine list; the site does not generate a regimen from age.
- Do not use potassium supplements or potassium-containing salt substitutes without professional review. NSAIDs such as ibuprofen or naproxen, lithium, other renin-angiotensin-system medicines, aliskiren and other blood-pressure medicines require full-list review; aliskiren coadministration in diabetes is a labelled contraindication boundary.
- The current label limits simvastatin to 20 mg daily when used with amlodipine. The site does not change an individual's dose from this statement; if simvastatin is on the medicine list, have the exact product and prescription reviewed by a pharmacist or prescriber.
- The label carries a boxed warning for fetal toxicity. Anyone who is pregnant, may be pregnant or plans pregnancy should contact the prescribing team promptly; do not wait for a website decision or arrange stopping or switching independently.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-29
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. LOTREL amlodipine/benazepril hydrochloride public label (revised Aug 2023) ↗Current regulatory record · reviewed 2026-08-29
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current FDA/openFDA Orange Book data: LOTREL, NDA 020364; all six historical RLD strengths listed as Discontinued ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-29Current FDA/openFDA Drugs@FDA data: LOTREL NDA 020364 original approval, application holder and six discontinued product records ↗reviewed 2026-08-29
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about LOTREL (amlodipine and benazepril hydrochloride). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
LOTREL is the brand in this record and amlodipine and benazepril hydrochloride is the active-ingredient name. Check both with the dosage form (Amlodipine/benazepril hydrochloride fixed two-ingredient oral capsules: the current public label lists 5/10, 5/20, 10/20 and 10/40 mg; each paired number states the two ingredients in one capsule) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. LOTREL amlodipine/benazepril hydrochloride public label (revised Aug 2023) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA/openFDA Orange Book data: LOTREL, NDA 020364; all six historical RLD strengths listed as Discontinued ↗reviewed 2026-08-29
- Current FDA/openFDA Drugs@FDA data: LOTREL NDA 020364 original approval, application holder and six discontinued product records ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
How the two ingredients work together: amlodipine supports arterial relaxation and benazepril reduces angiotensin II formation
- Amlodipine may be associated with oedema, dizziness or hypotension, while benazepril may affect potassium and kidney function. The words 'blood pressure' must not replace symptoms, laboratory review and the complete medicine list.
- The four paired strengths are four complete labelled product identities. Different milligram pairs, colours, imprints and NDCs cannot be converted by the site into an individual increase, decrease, capsule opening, make-up use or alternation plan.
- Older or frail adults and people with kidney or liver impairment or volume depletion particularly need professional review using the actual packs and monitoring results. A publicly readable label does not mean that the brand is currently available.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. LOTREL amlodipine/benazepril hydrochloride public label (revised Aug 2023) ↗Current regulatory record · reviewed 2026-08-29
- Current FDA/openFDA Orange Book data: LOTREL, NDA 020364; all six historical RLD strengths listed as Discontinued ↗reviewed 2026-08-29
- Current FDA/openFDA Drugs@FDA data: LOTREL NDA 020364 original approval, application holder and six discontinued product records ↗reviewed 2026-08-29
- FDA: LOTREL NDA 020364/S-066 supplemental approval letter (10 Feb 2020) ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
LOTRELamlodipine and benazepril hydrochloride
This page includes an exact current U.S. public-label package panel for LOTREL, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Original LOTREL approval
Current Drugs@FDA data record the original approval of NDA 020364 as a new combination.
Current FDA/openFDA Drugs@FDA data: LOTREL NDA 020364 original approval, application holder and six discontinued product records ↗S-066 supplemental approval
The FDA public supplemental approval letter records a labelling milestone; it does not establish current market supply.
FDA: LOTREL NDA 020364/S-066 supplemental approval letter (10 Feb 2020) ↗Current public brand label revised
The current DailyMed page lists four strengths, four exact 100-capsule bottle panels and enlarged safety information.
DailyMed (NLM): current U.S. LOTREL amlodipine/benazepril hydrochloride public label (revised Aug 2023) ↗Current FDA data status reviewed
Orange Book and Drugs@FDA data list all six historical NDA 020364 strengths as RLD products, RS No and Discontinued.
Current FDA/openFDA Orange Book data: LOTREL, NDA 020364; all six historical RLD strengths listed as Discontinued ↗
MARKET SCOPE
Market-record boundary
United States
All six historical RLD strengths are currently listed as Discontinued; four dated brand-label panels remain publicly readableThe public label supports review of ingredients, strengths, packs, appearance and safety information; it does not establish pharmacy stock, purchasing eligibility or interchangeability.
Mainland China and other markets
Current market record not establishedNo local approval, trade name, pack, supply or interchangeability is inferred from the historical U.S. brand, shared ingredients or milligram numbers.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Does 10/20 mg mean half a capsule or two capsules?
Neither. It means one capsule contains amlodipine 10 mg and benazepril 20 mg. The site does not convert the paired numbers into opening, dividing, halving or an individual capsule count.
Can the capsule be opened and half the contents used to reduce the amount?
That conclusion cannot be drawn from capsule form or milligram numbers. The current public label establishes an intact capsule product identity and does not allow the site to provide an opening, dividing or halving plan. Check the exact bottle, prescription and pharmacist or prescriber advice.
Can NORVASC or another ACE inhibitor be taken in addition to LOTREL?
The site cannot decide for an individual. LOTREL already contains amlodipine and the ACE inhibitor benazepril; another same-ingredient or same-class product may be duplicative or intentionally prescribed. Only exact prescriptions, packs and the complete medicine list can establish that. Do not add or stop a pack yourself.
Why is the label still readable when FDA data say Discontinued?
A public label is a regulatory and safety-information record, not a live supply list. Current FDA data list all six historical RLD products as Discontinued, so this page does not present a readable label as current availability.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.