Ramelteon
- Product NDC
- 60687-692
- 11-digit product format
- 606870692
- Labeler code
- 60687
- Product ID
- 60687-692_1d9ab033-d6bb-3060-e063-6394a90a7c5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211567
- Marketing category
- ANDA
- Marketing start
- 2023-02-20
- 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 |
|---|
| 60687-692-11 | Ramelteon | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 60687-692-65 | Ramelteon | 50 in 1 CARTON | TABLET | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-692 | RAMELTEON TABLET [AMERICAN HEALTH PACKAGING] | 3 | Current NDC, 2 package rows | 20240720_094d5aa0-aa29-4898-928a-fe0d283a5271.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-692-11 | 60687069211 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-692-65 | 60687069265 | 50 BLISTER PACK in 1 CARTON (60687-692-65) / 1 TABLET in 1 BLISTER PACK (60687-692-11) | 50 blister pack | 2023-02-20 | No | No | Current |