Medicine
Quetiapine 50 mg tablet
Quetiapine 50 mg tablet is a generic prescription medicine for oral use, made by 34 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 at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Quetiapine
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 1000 tablets, 30 tablets and 114 more
- Manufacturers
- Alembic PharmaceuticalsIndiaAscend LaboratoriesIndiaCamber PharmaceuticalsIndiaAurobindo PharmaIndiaMacleods PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaUnichem LaboratoriesIndiaAccord HealthcareIndiaLupinIndiaXLCare Pharmaceuticals34 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- 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
- 26 March 2012
- Identifiers
- RxCUI 312743, 312744, 312745 +4DailyMed set ID 74e09734-26cb-42fe-b9a3-79cc10505e0b, 874e50ad-5da0-4ac3-9290-79442c91399e, e4ce9d50-9786-2233-e053-2a95a90a276f +37NDC 76420-513, 68001-180, 72189-366 +37Application ANDA201504, ANDA201109, ANDA091388 +9
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
A sample of 40 packs from 34 labelers. The register lists 117 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 16729-146-01 | Accord HealthcareIndia | 28 March 2012 |
| 1000 tablet, film coated in 1 bottle | 16729-146-17 | Accord HealthcareIndia | 28 March 2012 |
| 100 tablet, film coated in 1 carton | 46708-135-10 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 30 tablet, film coated in 1 bottle | 46708-135-30 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 100 tablet, film coated in 1 bottle | 46708-135-31 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 1000 tablet, film coated in 1 bottle | 46708-135-91 | Alembic PharmaceuticalsIndia | 21 February 2017 |
| 100 tablet, film coated in 1 bottle | 67877-249-01 | Ascend LaboratoriesIndia | 1 March 2013 |
| 1000 tablet, film coated in 1 bottle | 67877-249-10 | Ascend LaboratoriesIndia | 1 March 2013 |
| 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-249-33 | Ascend LaboratoriesIndia | 1 March 2013 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 67877-249-38 | Ascend LaboratoriesIndia | 1 March 2013 |
| 100 tablet, film coated in 1 bottle | 65862-490-01 | Aurobindo PharmaIndia | 27 March 2012 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 65862-490-10 | Aurobindo PharmaIndia | 27 March 2012 |
| 1000 tablet, film coated in 1 bottle | 65862-490-99 | Aurobindo PharmaIndia | 27 March 2012 |
| 100 tablet, film coated in 1 bottle | 31722-765-01 | Camber PharmaceuticalsIndia | 16 June 2022 |
| 500 tablet, film coated in 1 bottle | 31722-765-05 | Camber PharmaceuticalsIndia | 16 June 2022 |
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-765-32 | Camber PharmaceuticalsIndia | 16 June 2022 |
| 100 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 31722-765-34 | Camber PharmaceuticalsIndia | 16 June 2022 |
| 100 tablet in 1 bottle | 68180-446-01 | LupinIndia | 27 March 2012 |
| 1000 tablet in 1 bottle | 68180-446-03 | LupinIndia | 27 March 2012 |
| 100 tablet, film coated in 1 bottle | 33342-100-11 | Macleods PharmaceuticalsIndia | 14 June 2016 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 33342-100-12 | Macleods PharmaceuticalsIndia | 14 June 2016 |
| 1000 tablet, film coated in 1 bottle | 33342-100-44 | Macleods PharmaceuticalsIndia | 14 June 2016 |
| 10 blister pack in 1 box, unit-dose / 10 tablet, film coated in 1 blister pack | 47335-903-61 | Sun Pharmaceutical IndustriesIndia | 28 March 2012 |
| 30 tablet, film coated in 1 bottle | 47335-903-83 | Sun Pharmaceutical IndustriesIndia | 28 March 2012 |
| 100 tablet, film coated in 1 bottle | 47335-903-88 | Sun Pharmaceutical IndustriesIndia | 28 March 2012 |
| 100 tablet, film coated in 1 bottle, plastic | 29300-148-01 | Unichem LaboratoriesIndia | 1 July 2016 |
| 1000 tablet, film coated in 1 bottle, plastic | 29300-148-10 | Unichem LaboratoriesIndia | 1 July 2016 |
| 60 tablet, film coated in 1 bottle, plastic | 29300-148-16 | Unichem LaboratoriesIndia | 1 July 2016 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 0054-0229-20 | Hikma Pharmaceuticals | 27 March 2013 |
| 100 tablet in 1 bottle | 0054-0229-25 | Hikma Pharmaceuticals | 27 March 2013 |
| 1000 tablet in 1 bottle | 0054-0229-31 | Hikma Pharmaceuticals | 27 March 2012 |
| 100 tablet, film coated in 1 bottle | 16571-718-01 | Rising Pharma Holdings | 27 March 2012 |
| 1000 tablet, film coated in 1 bottle | 16571-718-10 | Rising Pharma Holdings | 27 March 2012 |
| 100 tablet in 1 bottle | 43547-519-10 | Solco Healthcare | 12 April 2022 |
| 1000 tablet in 1 bottle | 43547-519-11 | Solco Healthcare | 12 April 2022 |
| 100 tablet, film coated in 1 bottle | 0093-8166-01 | Teva Pharmaceuticals | 27 March 2012 |
| 100 tablet, film coated in 1 bottle | 72865-265-01 | XLCare Pharmaceuticals | 2 February 2024 |
| 500 tablet, film coated in 1 bottle | 72865-265-05 | XLCare Pharmaceuticals | 2 February 2024 |
| 1000 tablet, film coated in 1 bottle | 72865-265-10 | XLCare Pharmaceuticals | 22 July 2024 |
| 90 tablet, film coated in 1 bottle | 72865-265-90 | XLCare Pharmaceuticals | 22 July 2024 |
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 50 mg 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 50 mg 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.