Medicine
Trazodone 300 mg tablet
Trazodone 300 mg tablet is a generic prescription medicine for oral use, made by 11 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°C to 25°C (68°F to 77°F). Excursions permitted between 15ºC and…
Key facts
- Active ingredient (INN)
- Trazodone
- Brand
- Sold under the generic name
- Strength
- 300 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 31 more
- Manufacturers
- Zydus LifesciencesIndiaAurolife PharmaIndiaGranules IndiaIndiaAccord HealthcareIndiaTorrent PharmaceuticalsIndiaAsclemedApotexBryant Ranch PrepackDirect_RxRising Pharma Holdings
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15ºC and 30ºC (59°F to 86ºF).
- 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
- 5 January 2009
- Identifiers
- RxCUI 856369, 856364, 856373 +1DailyMed set ID 470a98a2-4e68-4c98-b3c8-e5eba4e55cdc, 04a676ee-358e-484d-9de4-a9a88d908ba8, 9c4da6ad-d4d1-4e8c-918d-8ac48512a93f +10NDC 71335-3025, 76420-676, 0555-0711 +10Application ANDA204852, ANDA205253, ANDA071196 +4
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 |
|---|---|---|---|
| 100 tablet in 1 bottle | 68382-808-01 | Zydus LifesciencesIndia | 11 December 2017 |
| 500 tablet in 1 bottle | 68382-808-05 | Zydus LifesciencesIndia | 11 December 2017 |
| 30 tablet in 1 bottle | 68382-808-06 | Zydus LifesciencesIndia | 11 December 2017 |
| 1000 tablet in 1 bottle | 68382-808-10 | Zydus LifesciencesIndia | 11 December 2017 |
| 90 tablet in 1 bottle | 68382-808-16 | Zydus LifesciencesIndia | 11 December 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 68382-808-77 | Zydus LifesciencesIndia | 11 December 2017 |
| 1000 tablet in 1 bottle | 70771-1131-0 | Zydus LifesciencesIndia | 11 December 2017 |
| 100 tablet in 1 bottle | 70771-1131-1 | Zydus LifesciencesIndia | 11 December 2017 |
| 30 tablet in 1 bottle | 70771-1131-3 | Zydus LifesciencesIndia | 11 December 2017 |
| 10 blister pack in 1 carton / 10 tablet in 1 blister pack | 70771-1131-4 | Zydus LifesciencesIndia | 11 December 2017 |
| 500 tablet in 1 bottle | 70771-1131-5 | Zydus LifesciencesIndia | 11 December 2017 |
| 90 tablet in 1 bottle | 70771-1131-9 | Zydus LifesciencesIndia | 11 December 2017 |
| 100 tablet in 1 bottle | 16729-302-01 | Accord HealthcareIndia | 25 October 2018 |
| 100 tablet in 1 bottle | 13107-082-01 | Aurolife PharmaIndia | 15 September 2015 |
| 500 tablet in 1 bottle | 13107-082-05 | Aurolife PharmaIndia | 15 September 2015 |
| 30 tablet in 1 bottle | 13107-082-30 | Aurolife PharmaIndia | 15 September 2015 |
| 1000 tablet in 1 bottle | 13107-082-99 | Aurolife PharmaIndia | 15 September 2015 |
| 100 tablet in 1 bottle | 70010-234-01 | Granules IndiaIndia | 9 August 2024 |
| 30 tablet in 1 bottle | 70010-234-03 | Granules IndiaIndia | 9 August 2024 |
| 500 tablet in 1 bottle | 70010-234-05 | Granules IndiaIndia | 9 August 2024 |
| 100 tablet in 1 bottle | 13668-333-01 | Torrent PharmaceuticalsIndia | 27 November 2013 |
| 100 tablet in 1 bottle | 60505-2659-1 | Apotex | 5 January 2009 |
| 500 tablet in 1 bottle | 60505-2659-5 | Apotex | 5 January 2009 |
| 1400 tablet in 1 bottle | 60505-2659-7 | Apotex | 5 January 2009 |
| 100 tablet in 1 bottle | 64980-675-01 | Rising Pharma Holdings | 29 January 2025 |
| 100 tablet in 1 bottle | 0555-0711-02 | Teva Pharmaceuticals | 9 December 2021 |
| 500 tablet in 1 bottle | 71335-3025-1 | Bryant Ranch Prepack | 4 December 2025 |
| 100 tablet in 1 bottle | 72162-2533-1 | Bryant Ranch Prepack | 19 September 2025 |
| 500 tablet in 1 bottle | 72162-2533-5 | Bryant Ranch Prepack | 19 September 2025 |
| 100 tablet in 1 bottle | 76420-676-01 | Asclemed | 26 February 2024 |
| 30 tablet in 1 bottle | 76420-676-30 | Asclemed | 26 February 2024 |
| 60 tablet in 1 bottle | 76420-676-60 | Asclemed | 26 February 2024 |
| 90 tablet in 1 bottle | 76420-676-90 | Asclemed | 26 February 2024 |
| 30 tablet in 1 bottle | 72189-569-30 | Direct_Rx | 16 August 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 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 300 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.