Medicine
Rozerem 8 mg tablet
Rozerem 8 mg tablet is a prescription medicine containing Ramelteon for oral use, marketed by Takeda 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Keep…
Key facts
- Active ingredient (INN)
- Ramelteon
- Brand
- Rozerem
- Strength
- 8 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Keep container tightly closed and protected from moisture and humidity.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N05CH02 Ramelteon
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 22 July 2005
- Identifiers
- RxCUI 577348, 603162DailyMed set ID 9de82310-70e8-47b9-b1fc-6c6848b99455NDC 64764-805Application NDA021782
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 |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 64764-805-10 | Takeda Pharmaceuticals | 22 July 2005 |
| 30 tablet, film coated in 1 bottle | 64764-805-30 | Takeda Pharmaceuticals | 22 July 2005 |
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 22 July 2005 | 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 Ramelteon 8 mg tablet.
Clinical summary
Ramelteon is a melatonin receptor agonist indicated for the treatment of insomnia characterized by difficulty with sleep onset. It is available as tablets for oral use. MedsAcross supplies Ramelteon 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 RamelteonFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Rozerem prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Rozerem 8 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.