RAMELTEON
- Product NDC
- 76420-880
- 11-digit product format
- 764200880
- Labeler code
- 76420
- Product ID
- 76420-880_2bea370a-97da-d286-e063-6294a90aca7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RAMELTEON
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA215972
- Marketing category
- ANDA
- Marketing start
- 2023-07-10
- 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 |
|---|
| 76420-880-01 | RAMELTEON | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 76420-880-30 | RAMELTEON | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 76420-880-60 | RAMELTEON | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
| 76420-880-90 | RAMELTEON | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-880 | RAMELTEON TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 4 package rows | 20250122_8213998f-9a14-4ebb-a87a-4f33416dfb21.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-880-01 | 76420088001 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-880-01) | 2025-01-17 | No | No | Current |
| 76420-880-30 | 76420088030 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-880-30) | 2025-01-17 | No | No | Current |
| 76420-880-60 | 76420088060 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-880-60) | 2025-01-17 | No | No | Current |
| 76420-880-90 | 76420088090 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-880-90) | 2025-01-17 | No | No | Current |