Rozerem

Product NDC

63629-3389

11-digit product format

636293389

Labeler code

63629

Product ID

63629-3389_99c210cf-70b1-4884-a022-ce97addcb810

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ramelteon

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Bryant Ranch Prepack

Application

NDA021782

Marketing category

NDA

Marketing start

2005-07-22

Marketing end

0000-00-00

Substance

RAMELTEON

Active strength

8 mg/1

Pharmacologic classes

Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record