Ramelteon
- Product NDC
- 71335-2310
- 11-digit product format
- 713352310
- Labeler code
- 71335
- Product ID
- 71335-2310_7fbd3bf9-01ee-47ff-9b0e-49ebe55b3886
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA215243
- Marketing category
- ANDA
- Marketing start
- 2023-05-01
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2310-1 | 71335231001 | 30 TABLET in 1 BOTTLE (71335-2310-1) | 30 tablet | 2023-12-18 | No | No | Historical |
| 71335-2310-2 | 71335231002 | 60 TABLET in 1 BOTTLE (71335-2310-2) | 60 tablet | 2023-12-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ramelteon | Bryant Ranch Prepack | 2023-12-18 | HUMAN PRESCRIPTION DRUG LABEL | 100 |