Medicine
Quetiapine 300 mg extended-release tablet
Quetiapine 300 mg extended-release tablet is a generic prescription medicine for oral use, made by 14 labelers, 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 quetiapine extended-release tablets USP at 25ºC (77ºF), excursions…
Key facts
- Active ingredient (INN)
- Quetiapine
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 60 tablets, 100 tablets, 500 tablets and 23 more
- Manufacturers
- Aurobindo PharmaIndiaMacleods PharmaceuticalsIndiaAccord HealthcareIndiaLupinIndiaUnichem LaboratoriesIndiaIngenus PharmaceuticalsNovast LaboratoriesScieGen PharmaceuticalsSolco HealthcareACI Healthcare
- Origin register
- US FDA, United States
- Storage
- Store quetiapine extended-release tablets USP at 25ºC (77ºF), excursions permitted to 15 to 30ºC (59 to 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
- 22 August 2017
- Identifiers
- RxCUI 721791, 721794, 721796 +2DailyMed set ID b02324b1-e7f0-4cbc-8778-5f7c4a5d194a, 61695b42-cf71-43e3-8b5d-788fd439489f, 7803a290-91c0-4e7f-90b5-d2ff33a46cee +10NDC 0904-6804, 29300-311, 68180-615 +11Application ANDA204203, ANDA215478, ANDA208947 +5
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 60 tablet, extended release in 1 bottle | 16729-096-12 | Accord HealthcareIndia | 1 January 2019 |
| 100 tablet, film coated, extended release in 1 bottle | 65862-876-01 | Aurobindo PharmaIndia | 29 November 2017 |
| 500 tablet, film coated, extended release in 1 bottle | 65862-876-05 | Aurobindo PharmaIndia | 29 November 2017 |
| 60 tablet, film coated, extended release in 1 bottle | 65862-876-60 | Aurobindo PharmaIndia | 29 November 2017 |
| 60 tablet, film coated, extended release in 1 bottle | 68180-615-07 | LupinIndia | 22 August 2017 |
| 60 tablet, extended release in 1 bottle | 33342-136-09 | Macleods PharmaceuticalsIndia | 1 November 2017 |
| 500 tablet, extended release in 1 bottle | 33342-136-15 | Macleods PharmaceuticalsIndia | 1 November 2017 |
| 60 tablet, extended release in 1 bottle | 29300-311-16 | Unichem LaboratoriesIndia | 12 September 2022 |
| 60 tablet, film coated, extended release in 1 bottle | 71093-138-02 | ACI Healthcare | 1 February 2018 |
| 1000 tablet, extended release in 1 bottle | 50742-638-10 | Ingenus Pharmaceuticals | 31 August 2017 |
| 30 tablet, extended release in 1 bottle | 50742-638-30 | Ingenus Pharmaceuticals | 31 August 2017 |
| 60 tablet, extended release in 1 bottle | 50742-638-60 | Ingenus Pharmaceuticals | 31 August 2017 |
| 90 tablet, extended release in 1 bottle | 50742-638-90 | Ingenus Pharmaceuticals | 31 August 2017 |
| 1000 tablet, extended release in 1 bottle | 34908-638-10 | Novast Laboratories | 31 August 2017 |
| 30 tablet, extended release in 1 bottle | 34908-638-30 | Novast Laboratories | 31 August 2017 |
| 60 tablet, extended release in 1 bottle | 34908-638-60 | Novast Laboratories | 31 August 2017 |
| 90 tablet, extended release in 1 bottle | 34908-638-90 | Novast Laboratories | 31 August 2017 |
| 500 tablet, film coated, extended release in 1 bottle | 50228-383-05 | ScieGen Pharmaceuticals | 29 November 2017 |
| 30 tablet, film coated, extended release in 1 bottle | 50228-383-30 | ScieGen Pharmaceuticals | 29 November 2017 |
| 60 tablet, film coated, extended release in 1 bottle | 50228-383-60 | ScieGen Pharmaceuticals | 29 November 2017 |
| 60 tablet, extended release in 1 bottle | 43547-022-06 | Solco Healthcare | 1 April 2022 |
| 500 tablet, extended release in 1 bottle | 43547-022-50 | Solco Healthcare | 1 April 2022 |
| 60 tablet, extended release in 1 bottle | 68001-601-06 | BluePoint Laboratories | 28 November 2023 |
| 60 tablet, film coated, extended release in 1 bottle | 51407-802-60 | Golden State Medical Supply | 7 September 2023 |
| 100 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack | 0904-6804-61 | Major Pharmaceuticals | 22 August 2017 |
| 30 tablet, film coated, extended release in 1 blister pack | 70518-4769-0 | Remedyrepack | 8 October 2026 |
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 Quetiapine 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.