Ramelteon
- Product NDC
- 51407-523
- 11-digit product format
- 514070523
- Labeler code
- 51407
- Product ID
- 51407-523_2294061c-8ed1-8b41-e063-6394a90ada58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA216209
- Marketing category
- ANDA
- Marketing start
- 2022-11-25
- 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 |
|---|
| 51407-523-01 | Ramelteon | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 1 |
| 51407-523-30 | Ramelteon | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-523 | RAMELTEON TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 1 | Current NDC, 2 package rows | 20240922_229403c5-de9c-dc61-e063-6394a90a2a70.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51407-523-01 | 51407052301 | 100 TABLET, FILM COATED in 1 BOTTLE (51407-523-01) | 2024-08-29 | No | No | Current |
| 51407-523-30 | 51407052330 | 30 TABLET, FILM COATED in 1 BOTTLE (51407-523-30) | 2024-08-29 | No | No | Current |