Rozerem - 21695-183-30 - (ramelteon)

Alphabetical Index


Drug Information of Rozerem

Product NDC: 21695-183
Proprietary Name: Rozerem
Non Proprietary Name: ramelteon
Active Ingredient(s): 8    mg/1 & nbsp;   ramelteon
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Rozerem

Product NDC: 21695-183
Labeler Name: Rebel Distributors Corp
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021782
Marketing Category: NDA
Start Marketing Date: 20050722

Package Information of Rozerem

Package NDC: 21695-183-30
Package Description: 30 TABLET, FILM COATED in 1 BOTTLE (21695-183-30)

NDC Information of Rozerem

NDC Code 21695-183-30
Proprietary Name Rozerem
Package Description 30 TABLET, FILM COATED in 1 BOTTLE (21695-183-30)
Product NDC 21695-183
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name ramelteon
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20050722
Marketing Category Name NDA
Labeler Name Rebel Distributors Corp
Substance Name RAMELTEON
Strength Number 8
Strength Unit mg/1
Pharmaceutical Classes Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]

Complete Information of Rozerem


General Information