Ramelteon
- Product NDC
- 0904-7494
- 11-digit product format
- 009047494
- Labeler code
- 0904
- Product ID
- 0904-7494_da88d67f-2c67-461d-a910-263a6e036d83
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA211567
- Marketing category
- ANDA
- Marketing start
- 2025-01-10
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
- Listing expiration
- 2027-12-31
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 |
|---|
| 0904-7494-06 | Ramelteon | 50 in 1 CARTON | TABLET | 50 | | 2 |
| 0904-7494-06 | Ramelteon | 1 in 1 BLISTER PACK | TABLET | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-7494 | RAMELTEON TABLET [MAJOR PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20250112_44be28b2-f079-40ce-b86d-8b60eda1a7c0.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 |
|---|
| 0904-7494-06 | 00904749406 | 50 BLISTER PACK in 1 CARTON (0904-7494-06) / 1 TABLET in 1 BLISTER PACK | 50 blister pack | 2025-01-10 | No | No | Current |