Medicine
Ramelteon 8 mg tablet
Ramelteon 8 mg tablet is a generic prescription medicine for oral use, made by 24 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 25°C(77°F), excursions permitted to 15° to 30°C (59° to 86°F). Keep…
Key facts
- Active ingredient (INN)
- Ramelteon
- Brand
- Sold under the generic name
- Strength
- 8 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 30 tablets, 500 tablets and 84 more
- Manufacturers
- Zydus LifesciencesIndiaGranules IndiaIndiaMicro LabsIndiaAurobindo PharmaIndiaBryant Ranch Prepacki3 PharmaceuticalsXiromedActavis PharmaKanchan HealthcareTruPharma24 labelers on the register
- 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 2019
- Identifiers
- RxCUI 577348DailyMed set ID 32c52e03-4c2e-4774-9397-f1f0ee99b320, 2d22e6ae-2373-4a2f-8dda-d223230c6010, 5245f9ee-b4ca-24b6-e063-6394a90a0b1b +37NDC 72319-005, 0832-1250, 50268-822 +37Application ANDA212650, ANDA213815, ANDA215243 +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 24 labelers. The register lists 87 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet in 1 bottle | 70710-1344-1 | Zydus LifesciencesIndia | 23 July 2019 |
| 30 tablet in 1 bottle | 70710-1344-3 | Zydus LifesciencesIndia | 23 July 2019 |
| 500 tablet in 1 bottle | 70710-1344-5 | Zydus LifesciencesIndia | 23 July 2019 |
| 100 tablet in 1 bottle | 70771-1495-1 | Zydus LifesciencesIndia | 23 July 2019 |
| 30 tablet in 1 bottle | 70771-1495-3 | Zydus LifesciencesIndia | 23 July 2019 |
| 500 tablet in 1 bottle | 70771-1495-5 | Zydus LifesciencesIndia | 23 July 2019 |
| 100 tablet, film coated in 1 bottle | 59651-505-01 | Aurobindo PharmaIndia | 10 July 2023 |
| 30 tablet, film coated in 1 bottle | 59651-505-30 | Aurobindo PharmaIndia | 10 July 2023 |
| 100 tablet in 1 bottle | 70010-028-01 | Granules IndiaIndia | 15 May 2023 |
| 30 tablet in 1 bottle | 70010-028-03 | Granules IndiaIndia | 1 October 2020 |
| 500 tablet in 1 bottle | 70010-028-05 | Granules IndiaIndia | 1 October 2020 |
| 100 tablet in 1 bottle | 42571-375-01 | Micro LabsIndia | 1 May 2023 |
| 500 tablet in 1 bottle | 42571-375-05 | Micro LabsIndia | 1 May 2023 |
| 30 tablet in 1 bottle | 42571-375-30 | Micro LabsIndia | 1 May 2023 |
| 100 tablet in 1 bottle | 0591-2191-01 | Actavis Pharma | 22 July 2019 |
| 30 tablet in 1 bottle | 0591-2191-30 | Actavis Pharma | 22 July 2019 |
| 30 tablet, film coated in 1 bottle, plastic | 72319-005-01 | i3 Pharmaceuticals | 30 April 2020 |
| 100 tablet, film coated in 1 bottle, plastic | 72319-005-04 | i3 Pharmaceuticals | 30 April 2020 |
| 500 tablet, film coated in 1 bottle, plastic | 72319-005-05 | i3 Pharmaceuticals | 30 April 2020 |
| 30 tablet, film coated in 1 bottle, plastic | 85742-023-22 | Kanchan Healthcare | 21 April 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 85742-023-23 | Kanchan Healthcare | 21 April 2026 |
| 100 tablet, film coated in 1 bottle, plastic | 52817-235-10 | TruPharma | 30 June 2020 |
| 30 tablet, film coated in 1 bottle, plastic | 52817-235-30 | TruPharma | 30 June 2020 |
| 100 tablet, film coated in 1 bottle | 0832-1250-11 | Upsher-Smith Laboratories | 26 October 2020 |
| 30 tablet, film coated in 1 bottle | 0832-1250-30 | Upsher-Smith Laboratories | 26 October 2020 |
| 500 tablet, film coated in 1 bottle | 70700-272-05 | Xiromed | 25 November 2022 |
| 100 tablet, film coated in 1 bottle | 70700-272-10 | Xiromed | 25 November 2022 |
| 30 tablet, film coated in 1 bottle | 70700-272-30 | Xiromed | 25 November 2022 |
| 30 tablet in 1 bottle | 63629-8531-1 | Bryant Ranch Prepack | 1 October 2020 |
| 30 tablet in 1 bottle | 71335-1853-1 | Bryant Ranch Prepack | 21 December 2021 |
| 30 tablet, film coated in 1 bottle, plastic | 71335-2186-1 | Bryant Ranch Prepack | 4 November 2022 |
| 60 tablet, film coated in 1 bottle, plastic | 71335-2186-2 | Bryant Ranch Prepack | 4 November 2022 |
| 30 tablet in 1 bottle | 71335-2310-1 | Bryant Ranch Prepack | 18 December 2023 |
| 60 tablet in 1 bottle | 71335-2310-2 | Bryant Ranch Prepack | 18 December 2023 |
| 30 tablet, film coated in 1 bottle | 71335-2411-1 | Bryant Ranch Prepack | 10 June 2024 |
| 60 tablet, film coated in 1 bottle | 71335-2411-2 | Bryant Ranch Prepack | 10 June 2024 |
| 30 tablet, film coated in 1 bottle | 71335-2886-1 | Bryant Ranch Prepack | 28 October 2025 |
| 30 tablet, film coated in 1 bottle | 72162-2161-3 | Bryant Ranch Prepack | 26 October 2020 |
| 30 tablet in 1 bottle | 72162-2169-3 | Bryant Ranch Prepack | 7 December 2023 |
| 100 tablet, film coated in 1 bottle, plastic | 72162-2176-1 | Bryant Ranch Prepack | 7 December 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 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 Ramelteon 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.