What this pack is
IMDUR is the brand name in this record; isosorbide mononitrate extended-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
IMDURGeneric nameisosorbide mononitrate extended-release tablets
How this medicine works
Vasodilation can reduce cardiac workload and help prevent angina, while also explaining headache, dizziness and hypotension. Extended release prolongs delivery and does not turn it into immediate rescue for an acute attack.
Read source: United Kingdom ↗reviewed 2026-08-31More 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
- IMDUR
- Generic name
- isosorbide mononitrate extended-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 →
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.
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 · Historical product identity in the current FDA Orange Book dataset (1993-08-12)
Isosorbide mononitrate 30 mg per tablet; historical RLD currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020225 / Product 001
- Form and route
- IMDUR isosorbide mononitrate 30 mg oral extended-release tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- isosorbide mononitrate
- 30 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission
United States label · Historical product identity in the current FDA Orange Book dataset (1993-08-12)
Isosorbide mononitrate 60 mg per tablet; historical RLD currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020225 / Product 002
- Form and route
- IMDUR isosorbide mononitrate 60 mg oral extended-release tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- isosorbide mononitrate
- 60 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission
United States label · Historical product identity in the current FDA Orange Book dataset (1995-03-30)
Isosorbide mononitrate 120 mg per tablet; historical RLD currently DISCN
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- NDA 020225 / Product 003
- Form and route
- IMDUR isosorbide mononitrate 120 mg oral extended-release tablet (historical U.S. RLD) · oral (historical regulatory product-identity field)
- Listing review
- Cited product evidence reviewed 2026-08-31; actual marketing, stock and availability are not established.
- isosorbide mononitrate
- 120 mghistorical regulatory amount per tablet; not an individual's tablet count, frequency or splitting permission
GB · Current UK eMC SmPC (checked 31 Aug 2026)
Isosorbide mononitrate 60 mg per tablet; this exact UK product is divisible but must not be chewed or crushed
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PL 46500/0002
- Form and route
- Imdur isosorbide mononitrate 60 mg extended-release film-coated tablet (Durules) · oral
- Listing review
- Cited public label display reviewed 2026-08-31; actual marketing, stock and availability are not established.
- isosorbide mononitrate
- 60 mgamount per UK product tablet; divisibility applies only to this exact product and is not an individual plan
PACKAGE-VISUAL STATUS
No official principal pack image was obtained one-to-one for all four product identities
Only official text identities are shown. Retail images, current generics, MONOKET immediate-release tablets, nitroglycerin and look-alike tablets from another market are not substituted for IMDUR packs. Colour, imprint, score and divisibility require the exact product label.
LABEL READING · NOT A PRESCRIPTION
IMDUR enlarged label: a preventive extended-release medicine is not acute chest-pain rescue
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.
IMDUR is used to prevent angina, and the UK information states it is not for relief of an acute attack. Acute chest pain requires the existing emergency plan and local urgent-care pathway; the site does not generate rescue steps or an individual dose.
- Do not self-convert, alternate or substitute IMDUR extended-release tablets, MONOKET immediate-release tablets and sublingual/buccal nitroglycerin from a nitrate family or milligram figures.
- PDE-5 inhibitors such as sildenafil, tadalafil or vardenafil with an organic nitrate may cause dangerous hypotension. Do not invent a separation interval to bypass the contraindication; promptly review the complete list with the prescriber.
- Dizziness, hypotension or syncope requires priority review with antihypertensives, diuretics, other vasodilators or alcohol. Unsteadiness on standing or a fall in an older person needs timely assessment.
- The exact UK 60 mg product is described as divisible but must not be chewed or crushed. This is not universal permission for every IMDUR, generic extended-release or other-market product.
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 checkUK electronic medicines compendium (emc) · United Kingdom · Public product information or patient leaflet · 2026-08-31
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 Kingdom · 1
- 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 routeUK eMC: current SmPC product information for Imdur 60 mg extended-release tablets ↗reviewed 2026-08-31
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 · 2026-08-29FDA Orange Book: historical IMDUR / isosorbide mononitrate NDA 020225 extended-release RLD records for 30/60/120 mg ↗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 IMDUR (isosorbide mononitrate extended-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
IMDUR is the brand in this record and isosorbide mononitrate extended-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.
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.
HOW IT WORKS · NOT A TREATMENT PLAN
How isosorbide mononitrate works: an organic nitrate relaxes vascular smooth muscle
- Extended release does not mean stronger; it means a different release process. Immediate-release tablet counts cannot be assembled to recreate it.
- Sharing a nitrate class does not make products identical; route, release design and clinical context must be checked together.
- Headache or dizziness is not a basis for self-increasing, reducing, stopping or switching treatment.
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.
SOURCE-TRACEABLE ARCHIVE
IMDURisosorbide mononitrate extended-release tablets
This page links to public primary-source material for IMDUR. 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
First UK authorisation of Imdur 60 mg
The current SmPC retains the brand, 60 mg extended-release tablet and authorisation number.
UK eMC: current SmPC product information for Imdur 60 mg extended-release tablets ↗Historical U.S. approval of 30 mg and 60 mg RLD products
Both are under NDA 020225 and currently DISCN.
FDA Orange Book: historical IMDUR / isosorbide mononitrate NDA 020225 extended-release RLD records for 30/60/120 mg ↗Historical U.S. approval of the 120 mg RLD product
It is likewise currently listed DISCN.
FDA Orange Book: historical IMDUR / isosorbide mononitrate NDA 020225 extended-release RLD records for 30/60/120 mg ↗
MARKET SCOPE
Market-record boundary
United States
All three historical RLD products are DISCNNot withdrawn for safety or effectiveness reasons; does not establish current brand supply.
United Kingdom
Current 60 mg product information readablePL 46500/0002; actual supply still requires local checking.
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
Can I take an extra IMDUR tablet during chest pain?
Do not do this from a website. IMDUR is a preventive extended-release medicine, not acute rescue; sudden or worsening chest pain requires the existing emergency plan and local urgent-care pathway.
Does a score mean every 60 mg tablet can be halved?
Do not generalise. The exact UK Imdur 60 mg information permits division but not chewing or crushing; every other manufacturer and market requires its exact label.
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.