RAMELTEON
- Product NDC
- 71335-2411
- 11-digit product format
- 713352411
- Labeler code
- 71335
- Product ID
- 71335-2411_ff6df4b3-ebb1-4be5-bb08-8a255ad82a59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RAMELTEON
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 71335-2411-1 | RAMELTEON | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 71335-2411-2 | RAMELTEON | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-2411 | RAMELTEON TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1 | Current NDC, 2 package rows | 20240612_7b9b6076-180e-428b-b50a-5ab68ff65919.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2411-1 | 71335241101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2411-1) | 2024-06-10 | No | No | Current |
| 71335-2411-2 | 71335241102 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2411-2) | 2024-06-10 | No | No | Current |