Skip to content
LookupMeds

Active ingredient

Ramelteon

41 finished FDA listings contain Ramelteon as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
RAMELTEON
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
28
Strengths listed
8 mg/1
Brand names in FDA listings
Rozerem

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 596205

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021782TAKEDA PHARMS USA2005-07-221
ANDA 091693DR REDDYS LABS SA2013-07-261
ANDA 091610ACTAVIS LABS FL INC2015-08-191
ANDA 211567ZYDUS PHARMS2019-07-227
ANDA 212650PHARMAZONE2020-04-108
ANDA 213186GRANULES2020-08-214
ANDA 213815APPCO2020-10-265
ANDA 215435ANDAS 5 HOLDING2022-08-243
ANDA 216209XIROMED2022-11-252
ANDA 215243MICRO LABS2023-02-096
ANDA 215972AUROBINDO PHARMA LTD2023-07-103

Official labeling on DailyMed

Showing the 12 most recent of 41 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.