Drug
Who makes quetiapine?
29 companies list quetiapine as a human prescription drug, including under the names SEROQUEL, SEROQUEL XR. Forms: tablet; tablet, extended release; tablet, film coated; tablet, film coated, extended release. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing quetiapine
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| BluePoint Laboratories Inc. | tablet; tablet, extended release | ANDAANDA201109, ANDA215478 | 11 | 0 |
| H2-Pharma, LLC | tablet, extended release; tablet, film coated | NDANDA020639, NDA022047 | 11 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated; tablet, film coated, extended release | ANDAANDA201504, ANDA204203 | 11 | 0 |
| Solco healthcare U.S., LLC | tablet; tablet, extended release | ANDAANDA206954, ANDA208781 | 11 | 0 |
| AstraZeneca PLCUnited States | tablet, extended release; tablet, film coated | NDANDA020639, NDA022047 | 10 | 15 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet, film coated | ANDAANDA201504 | 7 | 1 |
| ASCEND Therapeutics US, LLC | tablet, film coated | ANDAANDA201504 | 7 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet, film coated | ANDAANDA077745 | 6 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA201109 | 6 | 5 |
| Coupler LLCUnited States | tablet; tablet, extended release; tablet, film coated | ANDAANDA201109, ANDA201504, ANDA215478 | 6 | 1 |
| RemedyRepack, IncUnited States | tablet, extended release; tablet, film coated; tablet, film coated, extended release | ANDAANDA201504, ANDA204253, ANDA209635 | 6 | 1 |
| Lupin LimitedIndia | tablet, film coated, extended release | ANDAANDA204203 | 5 | 14 |
| Aurobindo Pharma LimitedIndia | tablet, film coated, extended release | ANDAANDA207655 | 5 | 6 |
| Unichem Laboratories Limited, IndiaIndia | tablet, extended release | ANDAANDA215478 | 5 | 5 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet, film coated, extended release | ANDAANDA209635 | 5 | 3 |
| ACI Healthcare USA, Inc.United States | tablet, film coated, extended release | ANDAANDA209635 | 5 | 2 |
| Golden State Medical Supply Inc.United States | tablet, film coated, extended release | ANDAANDA209635 | 5 | 1 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA201504 | 4 | 34 |
| Macleods Pharmaceuticals LimitedIndia | tablet, extended release | ANDAANDA204253 | 4 | 5 |
| Bryant Ranch PrepackUnited States | tablet, extended release; tablet, film coated | ANDAANDA201504, ANDA202152, ANDA204253 | 4 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA077745, ANDA202152 | 3 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA201109 | 3 | 1 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA202152 | 2 | 2 |
| AlignScience Pharma Inc. | tablet, film coated, extended release | ANDAANDA209497 | 2 | 0 |
| International Medication Systems, Ltd.United States | tablet, film coated | ANDAANDA201504 | 1 | 3 |
| NuCare Pharmaceuticals,Inc.United States | tablet, film coated, extended release | ANDAANDA209635 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA201504 | 1 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated, extended release | ANDAANDA209635 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, film coated | ANDAANDA077745 | 1 | 0 |
Enquiry
Common questions
- Who makes quetiapine?
- 29 companies list quetiapine as a human prescription drug in the openFDA NDC Directory, led by BluePoint Laboratories Inc., H2-Pharma, LLC, MAJOR Pharmaceuticals Inc., Solco healthcare U.S., LLC, AstraZeneca PLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic SEROQUEL?
- 27 companies list quetiapine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.