Ramelteon
- Product NDC
- 80425-0343
- 11-digit product format
- 804250343
- Labeler code
- 80425
- Product ID
- 80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA213815
- Marketing category
- ANDA
- Marketing start
- 2023-06-15
- 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 |
|---|
| 80425-0343-1 | 80425034301 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1) | 2023-06-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ramelteon Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 2 |