What this pack is
SEROQUEL XR is the brand name in this record; quetiapine fumarate extended-release tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
SEROQUEL XRGeneric namequetiapine fumarate extended-release tablets
How this medicine works
The current label says the full mechanism of SEROQUEL XR in its listed indications is unknown; pharmacologic activity may involve dopamine D2 and serotonin 5HT2A receptor antagonism. The extended-release design changes the release process, but neither the receptor description nor XR structure predicts individual suitability, response, strength or co-use with another psychiatric medicine.
Read source: United States ↗Current regulatory record · reviewed 2026-08-30More 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
- SEROQUEL XR
- Generic name
- quetiapine fumarate extended-release tablets
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- 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.
5 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 (SPL v50; updated 10 Apr and published 13 Apr 2026)
Quetiapine 50 mg per tablet; 60-tablet bottle
- Product code
- NDC 61269-270-60
- Form and route
- SEROQUEL XR quetiapine oral film-coated extended-release tablet · oral; current label says swallow the extended-release tablet whole and do not split, chew or crush
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- quetiapine (supplied as quetiapine fumarate)
- 50 mglabelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- peach · capsule-shaped, biconvex, film-coated extended-release tablet; unscored · imprint XR 50Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)
Quetiapine 150 mg per tablet; 60-tablet bottle
- Product code
- NDC 61269-271-60
- Form and route
- SEROQUEL XR quetiapine oral film-coated extended-release tablet · oral; current label says swallow the extended-release tablet whole and do not split, chew or crush
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- quetiapine (supplied as quetiapine fumarate)
- 150 mglabelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- white · capsule-shaped, biconvex, film-coated extended-release tablet; unscored · imprint XR 150Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)
Quetiapine 200 mg per tablet; 60-tablet bottle
- Product code
- NDC 61269-272-60
- Form and route
- SEROQUEL XR quetiapine oral film-coated extended-release tablet · oral; current label says swallow the extended-release tablet whole and do not split, chew or crush
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- quetiapine (supplied as quetiapine fumarate)
- 200 mglabelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- yellow · capsule-shaped, biconvex, film-coated extended-release tablet; unscored · imprint XR 200Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)
Quetiapine 300 mg per tablet; 60-tablet bottle
- Product code
- NDC 61269-273-60
- Form and route
- SEROQUEL XR quetiapine oral film-coated extended-release tablet · oral; current label says swallow the extended-release tablet whole and do not split, chew or crush
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- quetiapine (supplied as quetiapine fumarate)
- 300 mglabelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- pale yellow · capsule-shaped, biconvex, film-coated extended-release tablet; unscored · imprint XR 300Unscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v50; updated 10 Apr and published 13 Apr 2026)
Quetiapine 400 mg per tablet; 60-tablet bottle
- Product code
- NDC 61269-274-60
- Form and route
- SEROQUEL XR quetiapine oral film-coated extended-release tablet · oral; current label says swallow the extended-release tablet whole and do not split, chew or crush
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- quetiapine (supplied as quetiapine fumarate)
- 400 mglabelled quetiapine amount per tablet; not an individual's tablet count, timing, splitting, conversion or stopping instruction
- Package
- 60 tablets per bottle
- Labelled appearance
- white · capsule-shaped, biconvex, film-coated extended-release tablet; unscored · imprint XR 400Unscored in this labelled presentation
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
SEROQUEL XR label reading: read XR, mg per tablet and the swallow-whole rule together
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.
“XR” identifies an extended-release dosage form, not merely a brand suffix. The current label says swallow the tablet whole and do not split, chew or crush it, so the extended-release structure is not damaged. That rule cannot select anyone's strength, tablet count, timing, conversion from immediate-release tablets or stopping/switching steps.
- 50, 150, 200, 300 and 400 mg are labelled quetiapine amounts per tablet, not today's tablet count or frequency. All five NDCs are 60-tablet bottles, but strength, colour and imprint differ. Check the full brand, XR, mg per tablet, NDC and actual pack together.
- SEROQUEL immediate-release tablets and SEROQUEL XR share quetiapine and a brand family but have different release characteristics. Do not self-replace XR with immediate tablets, change immediate to XR, convert milligram-for-milligram, alternate days, combine, split, crush or chew a tablet because it is large.
- The current U.S. label carries a boxed warning about increased mortality in elderly patients with dementia-related psychosis and states that the product is not approved for that population. Older age, cognitive change, drowsiness, dizziness, orthostatic hypotension, fainting, falls, swallowing difficulty or polypharmacy warrants prompt review of the exact pack and complete medicine list by the local prescriber or pharmacist.
- The label makes strong CYP3A4 inhibitors or inducers, other centrally acting medicines, alcohol and products that may add to hypotension, drowsiness or fall risk priority professional checks. A website cannot decide co-use or spacing from names; list prescription medicines, non-prescription medicines, herbs and supplements together.
- Marked mental or behavioural change, thoughts of self-harm/suicide, fainting, a fall with injury, a severe allergy-like reaction, persistent fever with muscle rigidity, seizure, palpitations/chest discomfort or another acute serious concern requires immediate local emergency or crisis support. Do not wait for a webpage to decide interruption, make-up use or switching.
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 · 2026-08-30
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. SEROQUEL XR quetiapine extended-release-tablet public label, Medication Guide and five package panels (SPL v50; updated 10 Apr 2026) ↗Current regulatory record · reviewed 2026-08-30
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 SEROQUEL XR (quetiapine fumarate extended-release tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
SEROQUEL XR is the brand in this record and quetiapine fumarate 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.
HOW IT WORKS · NOT A TREATMENT PLAN
How quetiapine extended release works: the label describes receptor activity while the full therapeutic mechanism remains unknown
- “Acts at dopamine and serotonin receptors” is a pharmacology clue, not a tool for self-diagnosing, choosing or adjusting medicine from insomnia, mood, hallucinations, anxiety or behavioural change.
- An extended-release and immediate-release tablet may share the active ingredient without sharing a release profile, excipients, administration conditions, exposure pattern or label boundary. The current label lists lactose, microcrystalline cellulose, sodium citrate, hypromellose and magnesium stearate among the extended-release tablet excipients. An excipient difference alone does not establish better or worse effectiveness.
- A shared antipsychotic class, related receptor activity or common potential for drowsiness does not support self-combination, alternation, substitution or milligram conversion. Genetic testing is not the site's default answer for everyone; the treating team should decide whether any test is relevant using diagnosis, liver/kidney function, prior response and 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.
- DailyMed (NLM): current U.S. SEROQUEL XR quetiapine extended-release-tablet public label, Medication Guide and five package panels (SPL v50; updated 10 Apr 2026) ↗Current regulatory record · reviewed 2026-08-30
- FDA Drugs@FDA: SEROQUEL XR (quetiapine fumarate) NDA 022047 application record ↗Current regulatory record · reviewed 2026-08-30
- FDA: SEROQUEL XR NDA 022047 clinical review (records the 2007 product-approval history) ↗reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
SEROQUEL XRquetiapine fumarate extended-release tablets
This page includes an exact current U.S. public-label package panel for SEROQUEL XR, 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
U.S. SEROQUEL XR product approval history
FDA review material records the 2007 product-approval history of SEROQUEL XR extended-release tablets. This is regulatory history, not anyone's treatment start date.
FDA: SEROQUEL XR NDA 022047 clinical review (records the 2007 product-approval history) ↗Current DailyMed SPL v50 updated
The current public label was updated 10 Apr and published 13 Apr 2026, retaining five 60-tablet bottle panels. A label date does not establish local stock or purchase availability.
DailyMed (NLM): current U.S. SEROQUEL XR quetiapine extended-release-tablet public label, Medication Guide and five package panels (SPL v50; updated 10 Apr 2026) ↗
MARKET SCOPE
Market-record boundary
United States
Current brand label, Medication Guide, NDA record and five exact bottles linkedEach pack card represents only its strength, NDC, colour, imprint and 60-tablet bottle; it does not establish supply, individual suitability, authenticity or interchangeability with another quetiapine product.
Mainland China, EU, Japan and other markets
Current market records not yet establishedNo local trade name, approval, strength, holder, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, NDA, shared ingredient or packaging.
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 a large SEROQUEL XR tablet be split, crushed or chewed?
The current label explicitly says swallow whole and do not split, chew or crush. With swallowing difficulty, take the exact pack to the prescriber or pharmacist to discuss an appropriate product pathway rather than damaging the extended-release structure.
Can SEROQUEL immediate tablets and SEROQUEL XR be directly exchanged when the milligrams match?
Not from a shared ingredient or milligram figure. Immediate and XR tablets have different release characteristics, labels and product identities. The treating professional must arrange any conversion, timing, tablet count or stopping process using the exact prescription.
What if an older adult becomes drowsy, dizzy on standing or falls?
Contact local medical services promptly and take every actual pack and the complete medicine list. Fainting, a fall with injury, marked altered awareness, chest discomfort or another serious concern requires immediate emergency support; do not self-make up, halve or change to immediate-release tablets.
Will a generic extended-release tablet have exactly the same excipients or release design as SEROQUEL XR?
A shared active ingredient alone cannot establish that. Review the current target-market label, excipients, dosage form, strength and regulatory equivalence record separately. The site does not infer interchangeability from a name or appearance or decide which pack is better for an individual.
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.