Drugplain

RAMELTEON 8 mg/1

RAMELTEON · TABLET, FILM COATED · Aurobindo Pharma Limited

No Recall History
Plain English

Ramelteon is a prescription medication that works by activating melatonin receptors in the brain to help regulate sleep-wake cycles. It is used to treat insomnia, specifically to help people who have difficulty falling asleep.

Key Facts

Brand Name
RAMELTEON
Generic Name
RAMELTEON
NDC Code (Product)
59651-505
Manufacturer
Aurobindo Pharma Limited
Strength
8 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA215972
Drug Class
Melatonin Receptor Agonist [EPC]
Marketing Start
07/10/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective72 reports
off label use68 reports
nausea63 reports
decreased appetite60 reports
diarrhoea59 reports
insomnia58 reports
fatigue53 reports
pneumonia49 reports
fall47 reports
anaemia42 reports

Frequently Asked Questions

What is RAMELTEON used for?

Ramelteon is a prescription medication that works by activating melatonin receptors in the brain to help regulate sleep-wake cycles. It is used to treat insomnia, specifically to help people who have difficulty falling asleep.

Is RAMELTEON a controlled substance?

RAMELTEON is not classified as a controlled substance by the DEA.

What is the generic name for RAMELTEON?

The generic name for RAMELTEON is RAMELTEON. There are 11 other brand versions of RAMELTEON.

What is the NDC code for RAMELTEON 8 mg/1?

The NDC (National Drug Code) for RAMELTEON 8 mg/1 is 59651-505, listed by Aurobindo Pharma Limited.

Product NDC

59651-505

Package NDC

59651-505-01

Other RAMELTEON Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)