Medicine
Raldesy TM 10 mg/mL oral solution
Raldesy TM 10 mg/mL oral solution is a prescription medicine containing Trazodone for oral use, marketed by Validus 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 at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to…
Key facts
- Active ingredient (INN)
- Trazodone
- Brand
- Raldesy TM
- Strength
- 10 mg/mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 300 mL, 150 mL
- Marketing authorisation holder
- Validus Pharmaceuticals
- Manufacturer
- Validus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.
- 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
- 26 November 2024
- Identifiers
- RxCUI 856381, 2699618DailyMed set ID 34708cc1-b0b2-4fd0-b9f3-7f008b457fc9NDC 30698-455Application NDA218637
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 |
|---|---|---|---|
| 300 mL in 1 bottle | 30698-455-01 | Validus Pharmaceuticals | 26 November 2024 |
| 150 mL in 1 bottle | 30698-455-02 | Validus Pharmaceuticals | 26 November 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 Raldesy TM 10 mg/mL oral solution 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.