Ramelteon
- Product NDC
- 87063-189
- 11-digit product format
- 870630189
- Labeler code
- 87063
- Product ID
- 87063-189_51354e62-ab19-97a2-e063-6294a90ab08b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ASCLEMED USA INC.
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RAMELTEON | 8 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 901AS54I69 |
| Rxcui | 577348 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 87063-189-01 | 87063018901 | 100 TABLET in 1 BOTTLE (87063-189-01) | 100 tablet | 2026-05-07 | No | No | Current |
| 87063-189-05 | 87063018905 | 5 TABLET in 1 BOTTLE (87063-189-05) | 5 tablet | 2026-05-07 | No | No | Current |
| 87063-189-10 | 87063018910 | 10 TABLET in 1 BOTTLE (87063-189-10) | 10 tablet | 2026-05-07 | No | No | Current |
| 87063-189-20 | 87063018920 | 20 TABLET in 1 BOTTLE (87063-189-20) | 20 tablet | 2026-05-07 | No | No | Current |
| 87063-189-30 | 87063018930 | 30 TABLET in 1 BOTTLE (87063-189-30) | 30 tablet | 2026-05-07 | No | No | Current |
| 87063-189-60 | 87063018960 | 60 TABLET in 1 BOTTLE (87063-189-60) | 60 tablet | 2026-05-07 | No | No | Current |
| 87063-189-90 | 87063018990 | 90 TABLET in 1 BOTTLE (87063-189-90) | 90 tablet | 2026-05-07 | No | No | Current |