Ramelteon
- Product NDC
- 71335-2886
- 11-digit product format
- 713352886
- Labeler code
- 71335
- Product ID
- 71335-2886_f56a6da2-455b-4e56-acb3-aaf23586f819
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212650
- Marketing category
- ANDA
- Marketing start
- 2020-06-30
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 901AS54I69 | RAMELTEON | 196597-26-9 | RAMELTEON |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2886-1 | 71335288601 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2886-1) | 2025-10-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ramelteon | Bryant Ranch Prepack | 2025-10-28 | HUMAN PRESCRIPTION DRUG LABEL | 100 |