Medicine
Seroquel XR 300 mg extended-release tablet
Seroquel XR 300 mg extended-release tablet is a prescription medicine containing Quetiapine for oral use, marketed by AstraZeneca Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store SEROQUEL XR at 25ºC (77ºF), excursions permitted to 15-30ºC (59-86ºF).
Key facts
- Active ingredient (INN)
- Quetiapine
- Brand
- Seroquel XR
- Strength
- 300 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturers
- AstraZeneca PharmaceuticalsH2-Pharma
- Origin register
- US FDA, United States
- Storage
- Store SEROQUEL XR at 25ºC (77ºF), excursions permitted to 15-30ºC (59-86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05AH04 Quetiapine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 July 2007
- Identifiers
- RxCUI 721791, 721793, 721794 +7DailyMed set ID ab959a35-d0ba-4f18-8f2e-6619d88b16e3, 473a3ac4-67f4-4782-baa9-7f9bdd8761f4NDC 61269-273, 0310-0283Application NDA022047
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 0310-0283-60 | AstraZeneca Pharmaceuticals | 16 July 2007 |
| 60 tablet, extended release in 1 bottle | 61269-273-60 | H2-Pharma | 16 July 2007 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 26 September 1997 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Quetiapine 300 mg extended-release tablet.
Other strengths and forms of Quetiapine
Clinical summary
Quetiapine is an atypical antipsychotic indicated for the treatment of schizophrenia, among other approved uses. It is available as tablets and extended-release tablets for oral use. MedsAcross supplies Quetiapine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about QuetiapineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SEROQUEL prescribing information (H2-Pharma) · U.S. National Library of Medicine, DailyMed
Need Seroquel XR 300 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.