Ramelteon
- Product NDC
- 50268-708
- 11-digit product format
- 502680708
- Labeler code
- 50268
- Product ID
- 50268-708_3a9a3e15-b992-ab32-e063-6294a90aab3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA091693
- Marketing category
- ANDA
- Marketing start
- 2021-01-06
- Marketing end
- 2026-07-09
- Substance
- RAMELTEON
- Active strength
- 8 mg/1
- Pharmacologic classes
- Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ramelteon
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 |
|---|
| 50268-708-11 | Ramelteon | 1 in 1 BLISTER PACK | TABLET | 1 | | 5 |
| 50268-708-15 | Ramelteon | 50 in 1 BOX | TABLET | 50 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-708 | RAMELTEON TABLET [AVPAK] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250112_b83cb374-8b38-1e35-e053-2995a90aa527.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-708-11 | 50268070811 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-708-15 | 50268070815 | 50 BLISTER PACK in 1 BOX (50268-708-15) / 1 TABLET in 1 BLISTER PACK (50268-708-11) | 50 blister pack | 2021-01-06 | 2026-07-09 | No | No | Current |