Ramelteon
- Product NDC
- 72189-369
- 11-digit product format
- 721890369
- Labeler code
- 72189
- Product ID
- 72189-369_2c4cb1fb-ac2c-e34f-e063-6294a90a33ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA212650
- Marketing category
- ANDA
- Marketing start
- 2022-08-03
- 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 |
|---|
| 72189-369-30 | Ramelteon | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-369 | RAMELTEON TABLET, FILM COATED [DIRECT_RX] | 3 | Current NDC, Legacy NDC, 1 package rows | 20250123_e55aea01-80e6-60ae-e053-2995a90a9ca2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72189-369-30 | 72189036930 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-369-30) | 2022-08-03 | 0000-00-00 | No | No | Current |