FDA-filed SPL labeling · retrieved through openFDA

Quetiapine

Quetiapine is an atypical antipsychotic used to treat schizophrenia, bipolar disorder, and — in its extended-release form — major depressive disorder as an add-on therapy.

Brand names SeroquelSeroquel Xr
Drug class Atypical Antipsychotic
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 169 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 22, 2025
Clinical labels in scope 169
AvailabilityRx
Earliest approval/marketing year 1997
FDA-listed product records 1,021
Boxed warningYes
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Quetiapine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Quetiapine is a well-established antipsychotic that treats schizophrenia, bipolar disorder, and — in extended-release form — major depressive disorder as an add-on to antidepressants. It works well for many people but requires monitoring for metabolic changes, blood sugar, weight, and mood, especially early in treatment. Take it exactly as prescribed, don't stop suddenly without talking to your doctor, and keep all follow-up appointments.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert

Two serious risks carry the FDA's strongest warning (a "black box").

First: Elderly patients with dementia-related psychosis have a higher risk of death when treated with antipsychotic drugs like quetiapine. Most of these deaths were from heart problems or infections like pneumonia. Quetiapine extended-release tablets are not approved for this use.

Second: Antidepressants — and quetiapine is sometimes used alongside them — can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults (up to age 24) during the early weeks of treatment. Anyone starting this medication should be watched closely for worsening mood, new thoughts of self-harm, or unusual behavior changes. Families and caregivers should know to contact the prescriber right away if they notice these signs. Quetiapine extended-release tablets are not approved for children under age 10.

Read the full warning on DailyMed →

📖 Quetiapine: Patient Information Guide

A plain-language walkthrough of Quetiapine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Quetiapine is an atypical antipsychotic approved for several serious psychiatric conditions across different products and formulations.

  • Schizophrenia — approved for adults and adolescents (ages 13–17) in both tablet and extended-release tablet forms
  • Bipolar I disorder, manic or mixed episodes — approved for adults and children/adolescents (ages 10–17); may be used alone or combined with lithium or divalproex; both tablet and extended-release tablet forms
  • Bipolar disorder, depressive episodes — approved as monotherapy in adults; available in both tablet and extended-release tablet forms
  • Major depressive disorder (MDD), as add-on therapy — the extended-release tablet form only, added to an antidepressant in adults; the regular tablet is not approved for this use
⚙️How it works

Quetiapine works by blocking dopamine (D2) and serotonin (5HT2A) receptors in the brain — two chemical messaging systems closely tied to mood, thinking, and perception. When these receptors are overactive, they can contribute to symptoms like hallucinations, mania, or severe depression. By blocking them, quetiapine helps restore a more balanced signal. The body also converts quetiapine into an active form called norquetiapine, which binds even more strongly to serotonin receptors and adds to the overall effect.

Quetiapine also interacts with histamine, adrenergic, and muscarinic receptors — interactions that contribute to some of its side effects, like sedation and dry mouth.

💊How it's taken

How quetiapine is taken depends on the form. The regular tablet can be taken with or without food and is typically taken more than once a day. The extended-release tablet is taken once daily, preferably in the evening — swallow it whole (never split, crush, or chew it), and take it without food or with only a light snack (around 300 calories), because a high-fat meal can significantly increase how much drug your body absorbs.

  • Older adults are usually started at a lower dose with slower increases and careful monitoring
  • People with liver problems may also need a lower starting dose
  • Your prescriber will determine the right dose and schedule for your specific condition — always follow their instructions and your prescription label
🤒Side effects — in detail

The most common side effects of quetiapine include:

  • Sleepiness or sedation (very common)
  • Dry mouth
  • Dizziness, especially when standing up
  • Constipation
  • Increased appetite and weight gain
  • Indigestion
  • Fatigue
  • Fast heartbeat
  • Difficulty speaking clearly (dysarthria)
  • Nasal congestion

More serious reactions — including uncontrolled muscle movements (tardive dyskinesia), high fever with muscle rigidity (neuroleptic malignant syndrome), significant blood sugar changes, or new/worsening thoughts of self-harm — require prompt medical attention.

⚠️Warnings & precautions
  • Elderly patients with dementia-related psychosis: quetiapine is not approved for this use and carries a significantly higher risk of death — mostly from heart problems or infections.
  • Suicidal thoughts: antidepressants, including when combined with quetiapine, may increase suicidal thinking in children, teens, and young adults (up to age 24) early in treatment. Monitor closely and contact a doctor immediately if these emerge.
  • Metabolic changes: quetiapine can raise blood sugar (including triggering diabetes), worsen cholesterol levels, and cause significant weight gain. Regular monitoring is important.
  • Neuroleptic malignant syndrome (NMS): a rare, life-threatening reaction causing high fever, severe muscle rigidity, confusion, and irregular heartbeat. Stop the medication and seek emergency care immediately.
  • Tardive dyskinesia: long-term use can cause uncontrolled muscle movements that may be irreversible. Risk increases with duration of use.
  • Low blood pressure on standing: can cause dizziness or falls, especially in older adults or those with heart disease.
  • Cataracts: lens changes have been observed; eye exams are recommended at the start of treatment and every 6 months during long-term use.
  • Low white blood cell count: people with a prior history should be monitored closely; stop the drug at the first sign of a significant drop.
🔀What it interacts with

Quetiapine interacts with several medications and substances — some interactions can make it much stronger or weaker:

  • Strong CYP3A4 inhibitors (ketoconazole, ritonavir, itraconazole, nefazodone): dramatically increase quetiapine blood levels — dose reduction is required
  • Strong CYP3A4 inducers (phenytoin, rifampin, carbamazepine, St. John's Wort): dramatically lower quetiapine levels — dose may need to be increased up to 5-fold; when the inducer is stopped, quetiapine dose must be reduced again
  • Alcohol: adds to sedation and impairs thinking and motor control — limit or avoid while taking quetiapine
  • Other central nervous system depressants (sedatives, sleep aids, anti-anxiety drugs): increased sedation risk
  • Blood pressure medications: quetiapine can enhance their blood-pressure-lowering effect, increasing the risk of dizziness or fainting
  • Levodopa and dopamine agonists: quetiapine may reduce the effectiveness of these Parkinson's disease treatments
  • Anticholinergic (antimuscarinic) drugs: combining with quetiapine raises the risk of severe constipation and related gut problems

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your doctor if you have liver disease — quetiapine levels can build up and a lower starting dose is usually needed
  • Older adults with dementia should not take quetiapine — it is not approved and carries a higher risk of death in this group
  • Tell your doctor if you are pregnant; babies born to mothers who took quetiapine in the third trimester may have muscle movement problems or withdrawal symptoms at birth
  • Tell your doctor if you are breastfeeding — quetiapine is present in breast milk
  • Tell your doctor if you have diabetes or risk factors for it — quetiapine can raise blood sugar
  • Tell your doctor about any history of heart problems, irregular heartbeat, low blood pressure, or seizures
  • Tell your doctor if you have ever had a low white blood cell count
  • Tell your doctor about all other medications, including supplements and St. John's Wort — many interact with quetiapine
  • The extended-release tablet is not approved for children under age 10; age restrictions also apply to specific indications of the regular tablet
  • Tell your doctor if you have ever had an allergic reaction to quetiapine or any of its ingredients — anaphylaxis (a severe allergic reaction) has been reported
🚑If you take too much

Taking too much quetiapine can cause severe drowsiness, rapid heartbeat, low blood pressure, and anticholinergic effects like confusion or delirium. In serious overdoses, coma and heart rhythm problems have been reported. If you suspect an overdose, call Poison Control at 1-800-222-1222 or go to the emergency room immediately — do not wait for symptoms to worsen.

📡Pharmacodynamics — effects in the body

Quetiapine and its active metabolite norquetiapine bind to multiple neurotransmitter receptors in the brain, including dopamine, serotonin, histamine, muscarinic, and adrenergic receptors. This broad receptor activity is responsible for both its therapeutic effects and its side effects — for example, histamine H1 blockade contributes to sedation, and muscarinic M1 blockade contributes to dry mouth and constipation. In clinical trials, quetiapine was not associated with a persistent increase in the QT interval (a heart rhythm measurement), though QT prolongation has been reported in overdose cases and in patients taking other medications that affect heart rhythm or electrolyte balance.

🔬Pharmacokinetics — how your body processes it

After you take quetiapine, it reaches peak levels in the blood about 6 hours after an extended-release dose. It is extensively broken down by the liver — less than 1% leaves the body as unchanged drug. The main half-life (how long it takes for half the drug to leave your system) is about 7 hours for quetiapine and about 12 hours for its active metabolite norquetiapine; steady levels in the blood are typically reached within two days of regular dosing. Most of the drug is eliminated through urine (about 73%), with a smaller portion in stool. People with liver disease clear quetiapine more slowly, so lower doses are often needed; kidney disease does not require a dose adjustment.

📦How to store it

Store quetiapine extended-release tablets USP at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) .

📄 Written from Quetiapine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

199

Supplements & herbs that interact with Quetiapine

199 supplements and herbal products have documented interactions with Quetiapine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 147
  • Minor · 41
Every supplement checked against Quetiapine — ranked by severity The full interaction hub: 11 major · 147 moderate · 41 minor · every one linked to its full report. Check Quetiapine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Quetiapine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is quetiapine used for?
Quetiapine is approved to treat schizophrenia, bipolar disorder (both manic episodes and depressive episodes), and — in the extended-release form only — as an add-on to an antidepressant for major depressive disorder in adults. The specific form your doctor prescribes may depend on exactly which condition is being treated, so it's worth confirming which use applies to you.
Does it matter if I take quetiapine with food?
It depends on the form. If you're taking the regular tablet, you can take it with or without food — no restrictions. But if you're on the extended-release tablet, you should take it on an empty stomach or with only a light snack (about 300 calories). A high-fat meal can cause significantly more of the drug to be absorbed, which could increase side effects. Try to take it the same way each time.
Why does quetiapine make me so sleepy?
Sleepiness is actually one of the most common side effects — in some studies, more than half of patients reported it. Quetiapine blocks histamine receptors in the brain, which has a sedating effect. That's why it's often taken in the evening. For many people the drowsiness improves over the first few weeks, but if it's really affecting your daily life, talk to your doctor — your dose or timing may be adjustable.
Are there any serious warning signs I should know about?
Yes — a few are important to know. Call your doctor or get emergency help right away if you develop high fever, severe muscle stiffness, confusion, or irregular heartbeat — these could be signs of a rare but dangerous reaction called neuroleptic malignant syndrome (NMS). Also watch for uncontrolled or repetitive muscle movements (tardive dyskinesia) and report those promptly. And for anyone under 25 starting this medication, pay close attention to any worsening depression or new thoughts of self-harm, especially in the first few weeks — contact your doctor immediately if that happens.
Can I drink alcohol while taking quetiapine?
It's best to avoid it or keep it to an absolute minimum. Alcohol significantly adds to quetiapine's sedating effect and can impair your thinking and coordination more than either one would on its own. This combination can be risky, especially if you need to drive or operate machinery.
Is quetiapine safe to take during pregnancy?
This is something to discuss carefully with your doctor. Taking quetiapine in the third trimester has been linked to muscle movement problems and withdrawal symptoms in newborns after delivery. That said, untreated schizophrenia, bipolar disorder, or depression during pregnancy also carries real risks. Your doctor will help you weigh those risks together. If you become pregnant while taking quetiapine, don't stop it on your own — talk to your prescriber first.
Is Quetiapine available over the counter?
Quetiapine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Quetiapine first available?
Quetiapine has been available in the United States since at least 1997, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Quetiapine?
Quetiapine is supplied by 93 manufacturers listed in the FDA NDC Directory, including Remedyrepack Inc., Bryant Ranch Prepack, Aurobindo Pharma Limited.

💬 Answers drafted from Quetiapine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Quetiapine comes

Quetiapine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Seroquel
How this form is used
What it may be used for
  • Treats schizophrenia in adults and adolescents ages 13 to 17
  • Treats manic episodes of bipolar I disorder in adults and children ages 10 to 17, alone or with lithium or divalproex
  • Seroquel (tablet) is approved for depressive episodes associated with bipolar disorder in adults
Important instructions
  • Can be taken with or without food
  • Typically taken more than once daily — follow your prescriber's schedule
  • Older adults and people with liver problems should start at a lower dose with slower increases
  • Swallow as directed; follow your prescriber and label for your specific schedule
Available strengths 7 strengths
Show 1 more strength Show fewer strengths
753 FDA-listed product records

Extended-release tablet

By mouth
Brands Seroquel
How this form is used
What it may be used for
  • Treats schizophrenia in adults and adolescents ages 13 to 17
  • Treats manic or mixed episodes of bipolar I disorder in adults and children ages 10 to 17, alone or with lithium or divalproex
  • Treats depressive episodes of bipolar disorder in adults
  • Seroquel XR is approved as add-on therapy for major depressive disorder (MDD) in adults already taking an antidepressant
Important instructions
  • Swallow the tablet whole — do not split, crush, or chew it
  • Take without food or with only a light meal (about 300 calories); a high-fat meal significantly increases drug absorption
  • Take once daily, preferably in the evening
  • Older adults and people with liver problems should start at a lower dose with careful monitoring
Available strengths 5 strengths
234 FDA-listed product records

📊 Quetiapine across the U.S. market

How Quetiapine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms
93
Manufacturers
7
Brand names
1,021
FDA-listed product records
1997
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (34) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Remedyrepack Inc.9%
Bryant Ranch Prepack8%
Aurobindo Pharma Limited5%
Accord Healthcare Inc.4%
A-S Medication Solutions4%
BluePoint Laboratories4%
Other makers65%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Quetiapine is used

A general measure of how commonly Quetiapine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Quetiapine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

5,743,048
Medicaid prescriptions filled (Q1–Q4 2025)
$73.9M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Quetiapine prescribed? Of the 1,596 medications we measure, Quetiapine ranks #33 by Medicaid prescriptions — more than 98% of them.

Where Quetiapine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Quetiapine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 100 mg oral tablet is the most-dispensed Quetiapine product — about 23% of these Medicaid prescriptions.

quetiapine 100 MG Oral Tablet Most dispensed

1,316,242 Medicaid prescriptions (Q1–Q4 2025) 23% of Quetiapine prescriptions shown $13.9M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 24 of 210 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312743

quetiapine 50 MG Oral Tablet

1,303,263 Medicaid prescriptions (Q1–Q4 2025) 23% of Quetiapine prescriptions shown $13.2M gross reimbursement (before rebates) ≈ $10 per prescription (gross)

Summed across the 26 of 149 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616487

quetiapine 25 MG Oral Tablet

914,225 Medicaid prescriptions (Q1–Q4 2025) 16% of Quetiapine prescriptions shown $8.8M gross reimbursement (before rebates) ≈ $9.60 per prescription (gross)

Summed across the 24 of 193 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312744

quetiapine 200 MG Oral Tablet

695,409 Medicaid prescriptions (Q1–Q4 2025) 12% of Quetiapine prescriptions shown $8.8M gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 22 of 156 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 317174

quetiapine 300 MG Oral Tablet

542,233 Medicaid prescriptions (Q1–Q4 2025) 9% of Quetiapine prescriptions shown $8.3M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 26 of 128 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312745

quetiapine 400 MG Oral Tablet

445,276 Medicaid prescriptions (Q1–Q4 2025) 8% of Quetiapine prescriptions shown $7.8M gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 20 of 105 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616483

24 HR quetiapine 300 MG Extended Release Oral Tablet

102,576 Medicaid prescriptions (Q1–Q4 2025) 2% of Quetiapine prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $25 per prescription (gross)

Summed across the 9 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 721794

24 HR quetiapine 50 MG Extended Release Oral Tablet

102,183 Medicaid prescriptions (Q1–Q4 2025) 2% of Quetiapine prescriptions shown $1.5M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 7 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 853201

24 HR quetiapine 400 MG Extended Release Oral Tablet

90,106 Medicaid prescriptions (Q1–Q4 2025) 2% of Quetiapine prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $28 per prescription (gross)

Summed across the 9 of 37 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 721796

24 HR quetiapine 150 MG Extended Release Oral Tablet

81,343 Medicaid prescriptions (Q1–Q4 2025) 1% of Quetiapine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 9 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 895670

quetiapine 150 MG Oral Tablet

77,466 Medicaid prescriptions (Q1–Q4 2025) 1% of Quetiapine prescriptions shown $3.7M gross reimbursement (before rebates) ≈ $48 per prescription (gross)

Summed across the 1 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 389201

24 HR quetiapine 200 MG Extended Release Oral Tablet

72,726 Medicaid prescriptions (Q1–Q4 2025) 1% of Quetiapine prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $19 per prescription (gross)

Summed across the 9 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 721791

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Quetiapine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 186 of 1,134 listed Quetiapine NDCs with Medicaid activity.

🔍 Compare Quetiapine products

A representative set of FDA-listed product records for Quetiapine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 1,021 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1,021 Quetiapine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Quetiapine RxCUI 51272 2 dose forms · 12 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 374646 In current FDA listings
    Clinical drug / strength (SCD) 25 MG RxCUI 312744 50 MG RxCUI 616487 100 MG RxCUI 312743 150 MG RxCUI 389201 200 MG RxCUI 317174 300 MG RxCUI 312745 400 MG RxCUI 616483

Look up RxCUI 51272 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Seroquel Seroquel Xr

🏭 Manufacturers & labelers

Remedyrepack Inc. 83 Bryant Ranch Prepack 72 Aurobindo Pharma Limited 45 Accord Healthcare Inc. 39 A-S Medication Solutions 38 BluePoint Laboratories 33 Unichem Pharmaceuticals (USA), Inc. 33 Lupin Pharmaceuticals, Inc. 33 Golden State Medical Supply, Inc. 33 Major Pharmaceuticals 32 Ascend Laboratories, LLC 28 AstraZeneca Pharmaceuticals LP 26 Preferred Pharmaceuticals Inc. 25 NCS HealthCare of KY, LLC dba Vangard Labs 21 Rising Pharma Holdings, Inc. 21 Direct_Rx 20 Macleods Pharmaceuticals Limited 20 Sun Pharmaceutical Industries, Inc. 19 American Health Packaging 18 NorthStar Rx LLC 18 Ingenus Pharmaceuticals, LLC 15 AvKARE 13 Intas Pharmaceuticals Limited 12 Northstar RxLLC 12

…and 16 more on the FDA NDC directory.

RxNorm drug class

Quetiapine belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Diazepines, oxazepines, thiazepines and oxepines

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Quetiapine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Quetiapine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
169
NDC products indexed
1,021
Distinct labelers/manufacturers represented
93
Linked representative label
AstraZeneca Pharmaceuticals LP
Linked label effective
Jan 22, 2025
Composite sections available
25
Linked SPL Set ID
473a3ac4-67f4-4782-baa9-7f9bdd8761f4
Linked SPL Document ID
8e78eabf-6ff9-409b-ba1b-d9cb8d4f3fe0
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 169 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.