What this pack is
MONOPRIL is the brand name in this record; fosinopril sodium immediate-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
MONOPRILGeneric namefosinopril sodium immediate-release tablets
How this medicine works
Fosinopril is converted in the body to active fosinoprilat. ACE inhibition reduces angiotensin II formation and affects aldosterone-related pathways. ACE also participates in bradykinin breakdown, which helps explain why cough and angioedema require attention; mechanism cannot choose a medicine or dose for an individual.
Read source: United States ↗reviewed 2026-09-13More 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
- MONOPRIL
- Source-scoped market brand names
- MONOPRIL · United StatesHistorical regulator record ↗NDA 019915: historical 10/20/40 mg single-ingredient oral tablets are RLD entries and currently DISCN; regulatory history is not live supply.
- FOSINOPRIL SODIUM · United StatesSource-scoped evidence ↗The publicly readable current source is a Chartwell RX generic label; it is not rewritten as an original MONOPRIL pack.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- fosinopril sodium immediate-release tablets
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- No exact original-brand package image is shown This is deliberate: do not use a retailer, repackager or another-market image to identify the pack in hand. See why and what to check instead →
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 →
PACKAGE-VISUAL STATUS
MONOPRIL image withheld: a historical originator and a current generic label are not one package
This review retains the historical FDA identity for MONOPRIL and a current public generic fosinopril label, but no exact public image was retained that matches MONOPRIL, one strength, one pack and a primary source one-to-one. To avoid presenting generic, other-market, historical-version or source-uncertain imagery as the originator appearance, this page shows no package image.
LABEL READING · NOT A PRESCRIPTION
Fosinopril enlarged-label reading: first separate historical brand, per-tablet mg, combinations and class medicines
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.
Historical MONOPRIL 10/20/40 mg figures are fosinopril sodium strengths per tablet. They are not an individual's tablet count and cannot be self-interchanged from numbers with MONOPRIL-HCT, another ACE inhibitor or an ARB. The current public leaflet is generic and must be checked item by item against the pack in hand for ingredient, form, strength, market and document version.
- ACE-inhibitor labels carry a fetal-toxicity warning. Contact the prescriber promptly for pregnancy, possible pregnancy or pregnancy planning; this site creates no continuation, stopping or replacement plan.
- Swelling of the face, lips, tongue or throat—especially with breathing or swallowing difficulty—is an emergency angioedema signal. Do not wait for a website assessment.
- Potassium supplements or salt substitutes, a potassium-sparing diuretic, another ACE inhibitor/ARB, NSAID, lithium or a diuretic on the same list requires priority review of potassium, kidney function, hypotension and fall risk. Do not self-add, reduce, separate or stop when duplication is suspected.
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 · 2026-09-13
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 · 1
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. generic fosinopril sodium immediate-release tablet label (Chartwell RX; published 17 Nov 2025) ↗reviewed 2026-09-13
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 MONOPRIL (fosinopril sodium immediate-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
MONOPRIL is the brand in this record and fosinopril sodium immediate-release tablets is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How fosinopril works: ACE inhibition and the angiotensin II/bradykinin pathways
- MONOPRIL, LOTENSIN, ZESTRIL, VASOTEC, ALTACE, CAPOTEN and COVERSYL are not one medicine. A shared ACE-inhibitor mechanism does not establish milligram conversion, alternation or combination.
- Another renin-angiotensin-system medicine on the same list can increase risks of hypotension, hyperkalaemia and kidney impairment. A shared mechanism is not proof of greater benefit or suitability.
- A dry cough can be associated with ACE inhibitors, but breathing difficulty, throat tightness or face/lip/tongue swelling must not be dismissed as an ordinary cough and needs emergency action.
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.
- FDA Orange Book: historical MONOPRIL (fosinopril sodium) 10/20/40 mg oral-tablet RLD entries under NDA 019915; currently DISCN and not withdrawn for safety or effectiveness ↗reviewed 2026-09-13
- DailyMed (NLM): current U.S. generic fosinopril sodium immediate-release tablet label (Chartwell RX; published 17 Nov 2025) ↗reviewed 2026-09-13
SOURCE-TRACEABLE ARCHIVE
MONOPRILfosinopril sodium immediate-release tablets
This page links to public primary-source material for MONOPRIL. The archive is historical or documentary evidence only; it does not by itself establish originator status, product quality, current labelling, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
U.S. approval of MONOPRIL 10 mg and 20 mg
Two historical single-ingredient oral-tablet RLD entries under FDA NDA 019915.
FDA Orange Book: historical MONOPRIL (fosinopril sodium) 10/20/40 mg oral-tablet RLD entries under NDA 019915; currently DISCN and not withdrawn for safety or effectiveness ↗U.S. approval of MONOPRIL 40 mg
The third historical single-ingredient oral-tablet RLD entry under FDA NDA 019915.
FDA Orange Book: historical MONOPRIL (fosinopril sodium) 10/20/40 mg oral-tablet RLD entries under NDA 019915; currently DISCN and not withdrawn for safety or effectiveness ↗Current public generic label published
The Chartwell RX fosinopril sodium label supports reading current safety and class information; it does not replace historical MONOPRIL pack evidence.
DailyMed (NLM): current U.S. generic fosinopril sodium immediate-release tablet label (Chartwell RX; published 17 Nov 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Historical RLD; currently DISCNFDA historical RLD entries for MONOPRIL 10/20/40 mg are all DISCN and not withdrawn for safety or effectiveness; this is not live-supply evidence.
United States
Current public generic labelThe public leaflet is for Chartwell RX fosinopril sodium tablets and must be checked against the actual pack, NDC and label version.
Markets outside the United States
Local brand, approval, pack and supply are not established by this dossierNo other-market status is inferred from the U.S. historical RLD or generic label.
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.
RECORD FAQ
Record questions
Are MONOPRIL and MONOPRIL-HCT the same product?
No. MONOPRIL is fosinopril sodium alone, whereas MONOPRIL-HCT also contains hydrochlorothiazide. A shared name is not a basis for self-combination, substitution or conversion.
Do historical 10/20/40 mg strengths tell me how many tablets to take?
No. They are only per-tablet strengths for historical products. Individual tablet counts, frequency, kidney function, co-medications and any adjustment must be decided by the prescribing team using the actual pack, prescription, test results and complete medicine list.
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.