What this pack is
AGGRENOX is the brand name in this record; aspirin and extended-release dipyridamole capsules is the generic name. Read both together with the dosage form (oral capsule).
PACK CHECK · MARKET FIRST
AGGRENOXGeneric nameaspirin and extended-release dipyridamole capsules
How this medicine works
The label attributes antithrombotic action to additive antiplatelet effects of dipyridamole and aspirin. Aspirin irreversibly inhibits platelet cyclooxygenase and lowers thromboxane A2; dipyridamole augments adenosine-related signalling and inhibits cGMP phosphodiesterase. Mechanism explains the product design but cannot decide individual suitability.
Read source: United States ↗reviewed 2026-09-06More 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
- AGGRENOX
- Generic name
- aspirin and extended-release dipyridamole capsules
- Dosage-form class
- Each combination capsule contains one immediate-release aspirin 25 mg tablet and extended-release dipyridamole 200 mg pellets. The 25 and 200 figures belong to two ingredients, not one 225 mg medicine. Swallow the capsule whole and do not chew or crush it.
- 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.
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 · Historical U.S. DailyMed originator-brand label (effective 6 Aug 2016)
Each capsule contains aspirin 25 mg (immediate release) plus dipyridamole 200 mg (extended release); 60-count bottle; not one 225 mg ingredient
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 0597-0001-60 / NDA 020884
- Form and route
- AGGRENOX aspirin/extended-release dipyridamole combination capsule · oral; historical originator-brand product-identity field
- Container
- unit-of-use bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- aspirin (immediate-release sugar-coated tablet)
- 25 mglabelled aspirin amount in each combination capsule; not an individual's capsule count or frequency
- dipyridamole (extended-release pellets)
- 200 mglabelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen
- Package
- 60 capsules per bottle
- Labelled appearance
- red cap and ivory body; contains yellow extended-release pellets and one round white immediate-release aspirin tablet · hard-gelatin capsule; swallow whole and do not chew or crush · imprint Boehringer Ingelheim logo;01ACapsule; tablet score status does not apply
United States label · Historical 2012 DailyMed repackager label; source product NDC 0597-0001
Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; historical 60-count repackaged pack; image is a repackager label, not the originator carton or current stock
- Product code
- NDC 54868-5143-0 (source NDC 0597-0001)
- Form and route
- AGGRENOX aspirin/extended-release dipyridamole combination capsule · oral; historical repackager pack-identity field
- Container
- unit-of-use bottle
- Listing review
- Cited product evidence reviewed 2026-09-06; actual marketing, stock and availability are not established.
- aspirin (immediate-release sugar-coated tablet)
- 25 mglabelled aspirin amount in each combination capsule; not an individual's capsule count or frequency
- dipyridamole (extended-release pellets)
- 200 mglabelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen
- Package
- 60 capsules per bottle
- Labelled appearance
- red cap and ivory body; contains yellow extended-release pellets and one round white immediate-release aspirin tablet · hard-gelatin capsule; swallow whole and do not chew or crush · imprint Boehringer Ingelheim logo;01ACapsule; tablet score status does not apply
United States label · Current U.S. DailyMed generic label (revised Sep 2025)
Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; 30-count bottle; this is a current generic comparator, not an AGGRENOX originator-brand pack
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 68462-405-30
- Form and route
- aspirin 25 mg/extended-release dipyridamole 200 mg combination capsule · oral; current generic comparator
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-06; actual marketing, stock and availability are not established.
- aspirin (immediate-release sugar-coated tablet)
- 25 mglabelled aspirin amount in each combination capsule; not an individual's capsule count or frequency
- dipyridamole (extended-release pellets)
- 200 mglabelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen
- Package
- 30 capsules per bottle
- Labelled appearance
- reddish-brown opaque cap and cream opaque body · size 0el hard-gelatin capsule; contains light-yellow to yellow extended-release pellets and a white to off-white immediate-release tablet · imprint G;405Capsule; tablet score status does not apply
United States label · Current U.S. DailyMed generic label (revised Sep 2025)
Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; 60-count bottle; this is a current generic comparator, not an AGGRENOX originator-brand pack
- Product code
- NDC 68462-405-60
- Form and route
- aspirin 25 mg/extended-release dipyridamole 200 mg combination capsule · oral; current generic comparator
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-06; actual marketing, stock and availability are not established.
- aspirin (immediate-release sugar-coated tablet)
- 25 mglabelled aspirin amount in each combination capsule; not an individual's capsule count or frequency
- dipyridamole (extended-release pellets)
- 200 mglabelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen
- Package
- 60 capsules per bottle
- Labelled appearance
- reddish-brown opaque cap and cream opaque body · size 0el hard-gelatin capsule; contains light-yellow to yellow extended-release pellets and a white to off-white immediate-release tablet · imprint G;405Capsule; tablet score status does not apply
PACKAGE-VISUAL STATUS
When no current originator-pack image is available, leave it explicit rather than substitute a similar capsule
The historical originator label describes a red cap, ivory body, BI logo and 01A; the current generic is G/405. Each belongs only to its exact identity. The historical repackager image remains only in its matching repackager record and is not used as the originator hero visual; colour, shape, pellets or one label cannot establish authenticity.
LABEL READING · NOT A PRESCRIPTION
AGGRENOX enlarged label: two ingredients in one capsule—check duplication before bleeding alarms
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.
25 mg is the aspirin in each capsule and 200 mg is extended-release dipyridamole in that same capsule. They are not two capsules or a formulation to dismantle. The page supports ingredient, pack-number, whole-capsule and warning-signal literacy, not individual capsule counts, stopping/switching or missed-use plans.
- Swallow the capsule whole; do not chew or crush it. Do not self-assemble it from aspirin tablets and immediate-release dipyridamole, open it to divide pellets, discard the white tablet or take only part. Dysphagia requires pharmacist review of an exact alternative product.
- This combination already contains aspirin. Check active ingredients across prescriptions, OTC pain/cold products and supplements. If another aspirin, anticoagulant, antiplatelet, heparin, fibrinolytic, anagrelide or chronically used NSAID appears, do not self-combine it or assume timing separation removes risk.
- Vomiting blood or coffee-ground material, black or bloody stool, persistent or uncontrolled bleeding, severe headache with drowsiness, awareness or memory change, loss of consciousness, or new/worsening chest pain requires prompt local medical care; severe acute features require emergency help.
- Headache is not uncommon after initiation, but the site must not turn the label's clinician-directed alternative into self-adjustment. Severe or intolerable headache, planned pharmacologic stress testing, surgery/dental work, active peptic ulcer, kidney/liver problems, low blood pressure, myasthenia gravis, pregnancy or heavy alcohol use should be disclosed to the responsible team.
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 · 2026-09-06
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 · 2
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 label for aspirin 25 mg / extended-release dipyridamole 200 mg capsules (revised Sep 2025) ↗Current regulatory record · reviewed 2026-09-06
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 U.S. RLD/DISCN record for AGGRENOX NDA 020884 ↗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 AGGRENOX (aspirin and extended-release dipyridamole capsules). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
AGGRENOX is the brand in this record and aspirin and extended-release dipyridamole capsules is the active-ingredient name. Check both with the dosage form (Each combination capsule contains one immediate-release aspirin 25 mg tablet and extended-release dipyridamole 200 mg pellets. The 25 and 200 figures belong to two ingredients, not one 225 mg medicine. Swallow the capsule whole and do not chew or crush it.) 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. generic label for aspirin 25 mg / extended-release dipyridamole 200 mg capsules (revised Sep 2025) ↗Current regulatory record · reviewed 2026-09-06
- FDA Orange Book: historical U.S. RLD/DISCN record for AGGRENOX NDA 020884 ↗reviewed 2026-08-29
HOW IT WORKS · NOT A TREATMENT PLAN
Why two antiplatelet pathways: additive action does not permit adding more ‘blood thinners’
- AGGRENOX, aspirin alone, PLAVIX/clopidogrel, BRILINTA/ticagrelor, EFFIENT/prasugrel, PLETAL/cilostazol and oral anticoagulants differ in mechanism, product form and evidence boundaries. A shared antithrombotic purpose or milligram figure does not permit self-conversion, rotation or combination.
- Dipyridamole has vasodilatory effects, so headache, dizziness, low blood pressure or altered chest pain may occur. An older adult with a fall, fainting, marked weakness or changed chest pain should have the actual pack, blood-pressure record and complete medicine list reviewed together.
- The low-dose aspirin inside this combination does not mean it covers another cardiac indication, nor that extra aspirin should be added. The responsible team must review the exact indication and both bleeding and thrombotic risks.
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): historical U.S. AGGRENOX originator-brand label for aspirin 25 mg / extended-release dipyridamole 200 mg (effective 6 Aug 2016) ↗reviewed 2026-09-06
- DailyMed (NLM): historical repackager pack label for AGGRENOX 25 mg/200 mg, 60 capsules (Physicians Total Care; source NDC 0597-0001) ↗reviewed 2026-09-06
- DailyMed (NLM): current U.S. generic label for aspirin 25 mg / extended-release dipyridamole 200 mg capsules (revised Sep 2025) ↗Current regulatory record · reviewed 2026-09-06
- FDA: original approval label for AGGRENOX NDA 020884 (1999) ↗reviewed 2026-09-06
- FDA: original medical review for AGGRENOX NDA 020884 (ESPS2 and international development history) ↗reviewed 2026-09-06
- FDA Orange Book: historical U.S. RLD/DISCN record for AGGRENOX NDA 020884 ↗reviewed 2026-08-29
SOURCE-TRACEABLE ARCHIVE
AGGRENOXaspirin and extended-release dipyridamole capsules
This page links to public primary-source material for AGGRENOX. 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 initially approved AGGRENOX
The Orange Book lists 22 Nov 1999 for Product 001 under NDA 020884, and the original label states Initial U.S. Approval: 1999.
FDA Orange Book: historical U.S. RLD/DISCN record for AGGRENOX NDA 020884 ↗Original medical review records the fixed combination and ESPS2
FDA's medical review links the fixed extended-release dipyridamole/immediate-release aspirin combination to international Asasantine development and ESPS2. Historical evidence cannot itself establish an individual's present benefit.
FDA: original medical review for AGGRENOX NDA 020884 (ESPS2 and international development history) ↗Current Orange Book review: historical RLD/DISCN
Product 001 is an RLD, not the RS, and is DISCN, with a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons.
FDA Orange Book: historical U.S. RLD/DISCN record for AGGRENOX NDA 020884 ↗
MARKET SCOPE
Market-record boundary
United States
Historical originator RLD discontinued; current generic labels existThe page shows historical originator identity, one historical repackager label and current generic comparators. None establishes current AGGRENOX originator stock.
Mainland China, EU, Japan and other markets
Current market record not establishedNo local approval, brand, supply, reimbursement, originator/generic relationship or interchangeability is inferred from the U.S. NDA, Asasantine name or shared ingredients.
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
This capsule already contains aspirin. Can I add aspirin or a pain medicine?
Do not add one yourself. Have a pharmacist or clinician review every active ingredient across prescriptions, OTC pain/cold products and supplements; another aspirin, NSAID, antiplatelet or anticoagulant can change bleeding risk.
Does 25 mg plus 200 mg make one 225 mg medicine?
No. The 25 mg belongs to the immediate-release aspirin tablet and the 200 mg to extended-release dipyridamole pellets. They are separate ingredients and release designs and must not be summed for comparison or conversion to any 225 mg product.
Can the capsule be opened and half the contents used?
No. The label requires swallowing whole and not chewing or crushing. The capsule also contains two ingredients in different physical forms, so visual halving cannot preserve ingredient ratio or release. Ask a pharmacist to review an exact alternative for swallowing difficulty.
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.