Ramelteon
- Product NDC
- 0591-2191
- 11-digit product format
- 005912191
- Labeler code
- 0591
- Product ID
- 0591-2191_181ea308-f62b-48a0-81fc-a4654d679adb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA091610
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- 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 |
|---|
| 0591-2191-01 | Ramelteon | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 0591-2191-30 | Ramelteon | 30 in 1 BOTTLE | TABLET | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2191 | RAMELTEON TABLET [ACTAVIS PHARMA, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240302_a89dae05-6c39-4072-b8ee-c4c35b46f7d4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2191-01 | 00591219101 | 100 TABLET in 1 BOTTLE (0591-2191-01) | 100 tablet | 2019-07-22 | 0000-00-00 | No | No | Current |
| 0591-2191-30 | 00591219130 | 30 TABLET in 1 BOTTLE (0591-2191-30) | 30 tablet | 2019-07-22 | 0000-00-00 | No | No | Current |