What this pack is
MONOKET is the brand name in this record; isosorbide mononitrate is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
MONOKETGeneric nameisosorbide mononitrate
How this medicine works
The FDA historical MONOKET label identifies isosorbide mononitrate as an organic nitrate and describes its principal pharmacological action as relaxation of vascular smooth muscle, followed by dilation of peripheral arteries and veins. This mechanism overview only helps explain why blood pressure, dizziness, other nitrates and the complete medicine list need review together; it does not tell anyone what to do during chest pain, how many tablets to take, when to take them, or how to adjust, combine, stop or switch treatment.
Read source: United States ↗Historical public record · reviewed 2026-08-20More 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
- MONOKET
- Generic name
- isosorbide mononitrate
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Route documented in the linked source label
- 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.
2 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 · FDA U.S. historical prescribing information (revised Oct 2014)
Isosorbide mononitrate 10 mg per tablet; 100-tablet bottle (U.S. historical label)
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
- NDC 62175-3610-1
- Form and route
- MONOKET isosorbide mononitrate oral tablet · oral (historical-label product identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-26; actual marketing, stock and availability are not established.
- isosorbide mononitrate
- 10 mghistorical labelled amount per tablet; not an individual's tablet count, frequency, conversion or switching instruction
- Package
- 100 tablets per bottle
United States label · FDA U.S. historical prescribing information (revised Oct 2014)
Isosorbide mononitrate 20 mg per tablet; 100-tablet bottle (U.S. historical label)
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
- NDC 62175-3620-1
- Form and route
- MONOKET isosorbide mononitrate oral tablet · oral (historical-label product identity field)
- Container
- bottle
- Listing review
- Cited product evidence reviewed 2026-08-26; actual marketing, stock and availability are not established.
- isosorbide mononitrate
- 20 mghistorical labelled amount per tablet; not an individual's tablet count, frequency, conversion or switching instruction
- Package
- 100 tablets per bottle
PACKAGE-VISUAL STATUS
Historical-label text was reviewed, but no official package image matching one exact strength and package was retained, so no package visual is shown
This dossier retains MONOKET, isosorbide mononitrate, 10 mg/20 mg, two NDCs and each 100-tablet bottle as text identity fields from the FDA historical prescribing information. No official image that can safely be matched one to one to one strength, one NDC and one historical package was retained; to avoid treating a retail image, version-uncertain image, same-ingredient extended-release tablet, other nitrate or another-market image as an exact MONOKET pack, the page withholds package imagery and retains the primary document for enlarged reading.
LABEL READING · NOT A PRESCRIPTION
MONOKET historical label reading in larger print
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.
Read this FDA historical document first by exact brand, generic name, tablet form, labelled amount per tablet and target market; it does not replace today's prescription, current label or a professional's individual assessment.
- 10 mg and 20 mg are two separately listed historical tablet identities. A shared ingredient, nearby mg number or similar name is not a basis for self-adjusting, splitting, making up, alternating, substituting or converting another dosage form.
- Check MONOKET separately from same-ingredient extended-release tablets, other nitrates and similarly named products. If these appear on the actual pack or complete medicine list, ask a pharmacist or prescribing team to review them before any self-directed combining, spacing, switching or stopping.
- The cited 2014 document records contraindication warnings involving certain erectile-dysfunction medicines and riociguat. This is a historical-label reading cue, not personal advice to stop, combine or manage an urgent issue; any actual co-use question needs prompt confirmation by a professional who knows the complete medicine list.
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 checkFDA · United States · Regulatory product record or label archive · 2026-08-20
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 routeFDA: MONOKET (isosorbide mononitrate)10 mg／20 mg U.S.historicalprescribing information (2014-10 revised) ↗Historical public record · reviewed 2026-08-20
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 MONOKET (isosorbide mononitrate). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
MONOKET is the brand in this record and isosorbide mononitrate 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 isosorbide mononitrate works: the historical label describes relaxation of vascular smooth muscle
- “Vascular smooth-muscle relaxation” explains a pharmacological pathway. It does not make MONOKET 10 mg/20 mg tablets, same-ingredient extended-release tablets, isosorbide dinitrate, nitroglycerin or another cardiovascular medicine self-convertible by milligrams, combinable, separable or alternatable. Have a pharmacist or prescribing team review the exact packs and complete medicine list item by item.
- The historical label also explicitly states that this oral product does not act rapidly enough to abort an acute angina episode. Neither a mechanism page nor a historical document is an acute-chest-pain self-care guide; with new or worsening chest pain, fainting, marked breathing difficulty or another emergency symptom, use the local emergency pathway immediately rather than self-adjusting medicine from a webpage.
- The historical-label material on PDE5 inhibitors, riociguat, alcohol and other vasodilators is a cue for complete interaction review, not a webpage conclusion about an individual's stopping, co-use, spacing or urgent management. Any actual co-use or symptom concern needs prompt assessment by a professional who knows the complete medicine list.
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: MONOKET (isosorbide mononitrate)10 mg／20 mg U.S.historicalprescribing information (2014-10 revised) ↗Historical public record · reviewed 2026-08-20
- FDA: MONOKET (isosorbide mononitrate)10 mg／20 mg NDA 020215/S-027 supplemental approval letter (2022-02-01, corrected letter) ↗reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
MONOKETisosorbide mononitrate
This page links to public primary-source material for MONOKET. 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
FDA historical prescribing-information revision
The linked FDA prescribing information for MONOKET isosorbide mononitrate 10 mg/20 mg oral tablets is marked revised October 2014. It is a traceable historical-reading entry point, not a conclusion about current labeling, supply, holder, another-market status or individual use.
FDA: MONOKET (isosorbide mononitrate)10 mg／20 mg U.S.historicalprescribing information (2014-10 revised) ↗NDA 020215/S-027 supplemental approval (corrected letter)
The FDA corrected approval letter records approval on 1 Feb 2022 of a supplement for MONOKET 10 mg and 20 mg tablets, described as adding an alternate analytical testing facility for excipients. This regulatory node does not establish current labeling, current manufacturer, supply, individual use or sale eligibility in any market.
FDA: MONOKET (isosorbide mononitrate)10 mg／20 mg NDA 020215/S-027 supplemental approval letter (2022-02-01, corrected letter) ↗
MARKET SCOPE
Market-record boundary
United States
Historical label and supplemental-approval letter linkedOnly the FDA historical documents listed on this page are linked; current supply, labeling, holder and sale eligibility are not inferred.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, strength, supply, originator relationship or interchangeability is inferred from the U.S. historical documents.
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 this FDA historical document represent the current product in my hand or local pharmacy?
Not automatically. Its value is an entry point to the exact brand, generic name, historical tablet presentations and original document; current-product questions must return to the actual pack and the target market's current official label with professional review.
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.