Quick answers
- What is Quetiapine used for?
- The FDA-approved label (Seroquel, H2-Pharma, LLC, April 10, 2026) says: “SEROQUEL is an atypical antipsychotic indicated for the treatment of: • Schizophrenia • Bipolar I disorder manic episodes • Bipolar disorder, depressive episodes 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Quetiapine have a boxed warning?
- Yes. The FDA label for Seroquel has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Quetiapine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Quetiapine been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started February 27, 2020 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Quetiapine?
- 46 companies list prescription products of Quetiapine in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Aurobindo Pharma Limited.
What Quetiapine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SEROQUEL is an atypical antipsychotic indicated for the treatment of: • Schizophrenia • Bipolar I disorder manic episodes • Bipolar disorder, depressive episodes 1.1 Schizophrenia SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). …
— FDA label: Seroquel, H2-Pharma, LLC, effective April 10, 2026. Read the full label on DailyMed →
The FDA has 147 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
145 of 147 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Tablet, extended release · Tablet, film coated, extended release |
|---|---|
| Route | Oral |
| Prescription products | 349 in the FDA NDC Directory |
| Brand names | Seroquel, Seroquel XR |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| quetiapine fumarate 100 mg tablet | Generic | $0.0483 per tablet |
| quetiapine fumarate 100 mg tablet, film coated | Generic | $0.0483 per tablet |
| quetiapine fumarate 150 mg tablet, extended release | Generic | $0.1855 per tablet |
| quetiapine fumarate 150 mg tablet, film coated | Generic | $1.26 per tablet |
| quetiapine fumarate 150 mg tablet, film coated, extended release | Generic | $0.1855 per tablet |
| quetiapine fumarate 200 mg tablet | Generic | $0.0937 per tablet |
| quetiapine fumarate 200 mg tablet, extended release | Generic | $0.2179 per tablet |
| quetiapine fumarate 200 mg tablet, film coated | Generic | $0.0937 per tablet |
| quetiapine fumarate 200 mg tablet, film coated, extended release | Generic | $0.2179 per tablet |
| quetiapine fumarate 25 mg tablet | Generic | $0.0209 per tablet |
| quetiapine fumarate 25 mg tablet, film coated | Generic | $0.0209 per tablet |
| quetiapine fumarate 300 mg tablet | Generic | $0.1278 per tablet |
| quetiapine fumarate 300 mg tablet, extended release | Generic | $0.2557 per tablet |
| quetiapine fumarate 300 mg tablet, film coated | Generic | $0.1278 per tablet |
| quetiapine fumarate 300 mg tablet, film coated, extended release | Generic | $0.2557 per tablet |
| quetiapine fumarate 400 mg tablet | Generic | $0.1601 per tablet |
| quetiapine fumarate 400 mg tablet, extended release | Generic | $0.3172 per tablet |
| quetiapine fumarate 400 mg tablet, extended release | Brand: Seroquel XR | $26.36 per tablet |
| quetiapine fumarate 400 mg tablet, film coated | Generic | $0.1601 per tablet |
| quetiapine fumarate 400 mg tablet, film coated, extended release | Generic | $0.3172 per tablet |
| quetiapine fumarate 50 mg tablet | Generic | $0.0292 per tablet |
| quetiapine fumarate 50 mg tablet, extended release | Generic | $0.1239 per tablet |
| quetiapine fumarate 50 mg tablet, film coated | Generic | $0.0292 per tablet |
| quetiapine fumarate 50 mg tablet, film coated, extended release | Generic | $0.1239 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack27 products
- Remedyrepack Inc.20 products
- Aurobindo Pharma Limited12 products
- Direct_Rx11 products
- Major Pharmaceuticals11 products
- Accord Healthcare Inc.11 products
- Unichem Pharmaceuticals (USA), Inc.11 products
- BluePoint Laboratories11 products
- Golden State Medical Supply, Inc.11 products
- H2-Pharma, LLC11 products
- Proficient Rx LP11 products
- Lupin Pharmaceuticals, Inc.11 products
- Macleods Pharmaceuticals Limited10 products
- AstraZeneca Pharmaceuticals LP10 products
- Coupler LLC10 products
- A-S Medication Solutions9 products
- Preferred Pharmaceuticals Inc.8 products
- Rising Pharma Holdings, Inc.7 products
- Ascend Laboratories, LLC7 products
- Asclemed USA, Inc.7 products
- Aphena Pharma Solutions - Tennessee, LLC6 products
- NCS HealthCare of KY, LLC dba Vangard Labs6 products
- Teva Pharmaceuticals USA, Inc.6 products
- Camber Pharmaceuticals, Inc.6 products
- Alembic Pharmaceuticals Limited6 products
- AvPAK6 products
- American Health Packaging6 products
- NuCare Pharmaceuticals, Inc.6 products
- Hikma Pharmaceuticals USA Inc.6 products
- XLCare Pharmaceuticals, Inc.6 products
- Solco Healthcare US, LLC6 products
- Sun Pharmaceutical Industries, Inc.6 products
- NorthStar Rx LLC5 products
- Ingenus Pharmaceuticals, LLC5 products
- ScieGen Pharmaceuticals, Inc.5 products
- ACI Healthcare USA, Inc.5 products
- Solco Healthcare U.S., LLC5 products
- Unit Dose Solutions, Inc.4 products
- Novast Laboratories, Ltd.4 products
- St. Mary's Medical Park Pharmacy4 products
- Quallent Pharmaceuticals Health LLC4 products
- Cardinal Health 107, LLC4 products
- AlignScience Pharma Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Advanced Rx of Tennessee, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020639 SEROQUEL | Cheplapharm | September 26, 1997 | 48, latest January 22, 2025 2025: Labeling · 2022: Labeling · 2020: Labeling |
| NDA022047 SEROQUEL XR | Cheplapharm | May 17, 2007 | 34, latest January 22, 2025 2025: Labeling · 2022: Labeling · 2020: Labeling |
Generic approvals (23)
- ANDA077745Teva Pharms · March 27, 2012
- ANDA090120Hikma · March 27, 2012
- ANDA090749Hikma · March 27, 2012
- ANDA091388Aurobindo Pharma Ltd · March 27, 2012
- ANDA201109Lupin Ltd · March 27, 2012
- ANDA201190Sun Pharm · March 27, 2012
- ANDA202152Accord Hlthcare · March 27, 2012
- ANDA201504Alkem Labs Ltd · February 12, 2013
- ANDA203390Alembic · October 28, 2014
- ANDA202674Unichem · March 8, 2016
- ANDA203359Macleods Pharms · May 17, 2016
- ANDA090681Accord Hlthcare · November 1, 2016
- ANDA204203Lupin · May 17, 2017
- ANDA204253Macleods Pharms · November 29, 2017
- ANDA206252Accord Hlthcare · November 29, 2017
- ANDA207655Aurobindo Pharma · November 29, 2017
- ANDA208947Novast Labs · November 29, 2017
- ANDA209635Sciegen Pharms · November 29, 2017
- ANDA209497Alignscience Pharma · September 28, 2018
- ANDA208781Prinston Inc · April 26, 2022
- ANDA204316Hetero Labs Ltd V · June 16, 2022
- ANDA215478Unichem · August 15, 2022
- ANDA206954Prinston Inc · August 24, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
February 27, 2020 · Class III · Terminated · D-1002-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park — The Harvard Drug Group
-
February 27, 2020 · Class III · Terminated · D-1001-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park — The Harvard Drug Group
-
February 27, 2020 · Class III · Terminated · D-0999-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park D — The Harvard Drug Group
-
February 27, 2020 · Class III · Terminated · D-1000-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park — The Harvard Drug Group
-
November 14, 2018 · Class II · Terminated · D-0287-2019
Presence of Foreign Substance; metal shard found in tablet
Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: — Ascend Laboratories LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Seroquel, H2-Pharma, LLC, effective April 10, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →