Ramelteon
- Product NDC
- 76420-628
- 11-digit product format
- 764200628
- Labeler code
- 76420
- Product ID
- 76420-628_0b2fcb56-d9fa-e9f6-e063-6294a90a2f8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA211567
- Marketing category
- ANDA
- Marketing start
- 2019-07-23
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
- Listing expiration
- 2026-12-31
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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-628-01 | Ramelteon | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 76420-628-30 | Ramelteon | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 76420-628-60 | Ramelteon | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 76420-628-90 | Ramelteon | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-628 | RAMELTEON (RAMELTEON) TABLET [ASCLEMED USA, INC.] | 2 | Current NDC, 4 package rows | 20231129_208dbac2-2634-4aff-8e2c-e5ecb47145e2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-628-01 | 76420062801 | 100 TABLET in 1 BOTTLE (76420-628-01) | 100 tablet | 2023-10-17 | No | No | Current |
| 76420-628-30 | 76420062830 | 30 TABLET in 1 BOTTLE (76420-628-30) | 30 tablet | 2023-11-28 | No | No | Current |
| 76420-628-60 | 76420062860 | 60 TABLET in 1 BOTTLE (76420-628-60) | 60 tablet | 2023-11-28 | No | No | Current |
| 76420-628-90 | 76420062890 | 90 TABLET in 1 BOTTLE (76420-628-90) | 90 tablet | 2023-11-28 | No | No | Current |