Quick answers
- What is Seroquel?
- Seroquel is a brand name of Quetiapine, a prescription medicine. The FDA NDC Directory lists 12 Seroquel products in 6 strengths and forms.
- Who makes Seroquel?
- Cheplapharm holds the FDA application for Seroquel (NDA020639, approved September 26, 1997). 1 other company (repackagers or distributors) also list Seroquel products.
- Is there a generic or store brand of Seroquel?
- Yes. The FDA NDC Directory lists 151 other products with the same active ingredients, strength and form as a Seroquel product, 151 of them generic. Ask your pharmacist whether one is right for you.
- Has Seroquel been recalled?
- No recall linked to Seroquel products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Seroquel is
Each Seroquel product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Quetiapine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| quetiapine fumarate 100 mg tablet, film coated (oral) | Seroquel | 25 products, 21 companies | DailyMed |
| quetiapine fumarate 200 mg tablet, film coated (oral) | Seroquel | 27 products, 23 companies | DailyMed |
| quetiapine fumarate 25 mg tablet, film coated (oral) | Seroquel | 25 products, 23 companies | DailyMed |
| quetiapine fumarate 300 mg tablet, film coated (oral) | Seroquel | 24 products, 20 companies | DailyMed |
| quetiapine fumarate 400 mg tablet, film coated (oral) | Seroquel | 22 products, 20 companies | DailyMed |
| quetiapine fumarate 50 mg tablet, film coated (oral) | Seroquel | 28 products, 24 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Quetiapine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020639 | Cheplapharm | September 26, 1997 | 12 |
Companies that list Seroquel
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Seroquel products.
- H2-Pharma, LLC6 products
- AstraZeneca Pharmaceuticals LP6 products
Recalls
No recall linked to Seroquel products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.