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