Medicine
Trazodone 50 mg tablet
Trazodone 50 mg tablet is a generic prescription medicine for oral use, made by 32 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 between 15° to 30°C…
Key facts
- Active ingredient (INN)
- Trazodone
- Brand
- Sold under the generic name
- Strength
- 50 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 1000 tablets and 187 more
- Manufacturers
- Zydus LifesciencesIndiaAurolife PharmaIndiaGranules IndiaIndiaTorrent PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaOxford PharmaceuticalsApotex32 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F). Excursions permitted between 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
- N06AX05 Trazodone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 November 2008
- Identifiers
- RxCUI 856377, 856364, 856369 +1DailyMed set ID adc7427e-3553-4805-b063-eeda84049029, 04a676ee-358e-484d-9de4-a9a88d908ba8, 094ca37b-3ae2-4889-9536-e7e5f20e3105 +37NDC 71335-2651, 76420-672, 60687-443 +37Application ANDA202180, ANDA205253, ANDA218988 +7
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 32 labelers. The register lists 190 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 68382-609-01 | Zydus LifesciencesIndia | 22 January 2026 |
| 500 tablet in 1 bottle | 68382-609-05 | Zydus LifesciencesIndia | 22 January 2026 |
| 1000 tablet in 1 bottle | 68382-609-10 | Zydus LifesciencesIndia | 22 January 2026 |
| 100 tablet in 1 bottle | 68382-805-01 | Zydus LifesciencesIndia | 11 December 2017 |
| 500 tablet in 1 bottle | 68382-805-05 | Zydus LifesciencesIndia | 11 December 2017 |
| 30 tablet in 1 bottle | 68382-805-06 | Zydus LifesciencesIndia | 11 December 2017 |
| 1000 tablet in 1 bottle | 68382-805-10 | Zydus LifesciencesIndia | 11 December 2017 |
| 90 tablet in 1 bottle | 68382-805-16 | Zydus LifesciencesIndia | 11 December 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-805-77 | Zydus LifesciencesIndia | 11 December 2017 |
| 1000 tablet in 1 bottle | 70771-1128-0 | Zydus LifesciencesIndia | 11 December 2017 |
| 100 tablet in 1 bottle | 70771-1128-1 | Zydus LifesciencesIndia | 11 December 2017 |
| 30 tablet in 1 bottle | 70771-1128-3 | Zydus LifesciencesIndia | 11 December 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1128-4 | Zydus LifesciencesIndia | 11 December 2017 |
| 500 tablet in 1 bottle | 70771-1128-5 | Zydus LifesciencesIndia | 11 December 2017 |
| 90 tablet in 1 bottle | 70771-1128-9 | Zydus LifesciencesIndia | 11 December 2017 |
| 1000 tablet in 1 bottle | 70771-1938-0 | Zydus LifesciencesIndia | 22 January 2026 |
| 100 tablet in 1 bottle | 70771-1938-1 | Zydus LifesciencesIndia | 22 January 2026 |
| 500 tablet in 1 bottle | 70771-1938-5 | Zydus LifesciencesIndia | 22 January 2026 |
| 100 tablet in 1 bottle | 16729-299-01 | Accord HealthcareIndia | 5 October 2018 |
| 1000 tablet in 1 bottle | 16729-299-17 | Accord HealthcareIndia | 25 October 2018 |
| 100 tablet in 1 bottle | 13107-079-01 | Aurolife PharmaIndia | 15 September 2015 |
| 500 tablet in 1 bottle | 13107-079-05 | Aurolife PharmaIndia | 15 September 2015 |
| 30 tablet in 1 bottle | 13107-079-30 | Aurolife PharmaIndia | 15 September 2015 |
| 1000 tablet in 1 bottle | 13107-079-99 | Aurolife PharmaIndia | 15 September 2015 |
| 100 tablet in 1 bottle | 70010-231-01 | Granules IndiaIndia | 9 August 2024 |
| 30 tablet in 1 bottle | 70010-231-03 | Granules IndiaIndia | 9 August 2024 |
| 500 tablet in 1 bottle | 70010-231-05 | Granules IndiaIndia | 9 August 2024 |
| 1000 tablet in 1 bottle | 70010-231-10 | Granules IndiaIndia | 1 October 2024 |
| 100 tablet, film coated in 1 bottle, plastic | 57664-014-72 | Sun Pharmaceutical IndustriesIndia | 3 October 2022 |
| 500 tablet, film coated in 1 bottle, plastic | 57664-014-74 | Sun Pharmaceutical IndustriesIndia | 3 October 2022 |
| 1000 tablet, film coated in 1 bottle, plastic | 57664-014-75 | Sun Pharmaceutical IndustriesIndia | 3 October 2022 |
| 100 tablet in 1 bottle | 13668-330-01 | Torrent PharmaceuticalsIndia | 27 November 2013 |
| 500 tablet in 1 bottle | 13668-330-05 | Torrent PharmaceuticalsIndia | 27 November 2013 |
| 1000 tablet in 1 bottle | 13668-330-10 | Torrent PharmaceuticalsIndia | 27 November 2013 |
| 30 tablet in 1 bottle | 13668-330-30 | Torrent PharmaceuticalsIndia | 27 November 2013 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 60505-2653-0 | Apotex | 17 November 2008 |
| 100 tablet in 1 bottle | 60505-2653-1 | Apotex | 17 November 2008 |
| 90 tablet, film coated in 1 bottle, plastic | 69584-884-09 | Oxford Pharmaceuticals | 10 July 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 69584-884-10 | Oxford Pharmaceuticals | 1 January 2023 |
| 500 tablet, film coated in 1 bottle, plastic | 69584-884-50 | Oxford Pharmaceuticals | 1 January 2023 |
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 24 December 1981 | 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
Other strengths and forms of Trazodone
Clinical summary
Trazodone is a serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults. It is available as tablets and oral solution. MedsAcross supplies Trazodone 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 TrazodoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RALDESY TM prescribing information (Validus Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Trazodone 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.