Ramelteon
- Product NDC
- 70010-028
- 11-digit product format
- 700100028
- Labeler code
- 70010
- Product ID
- 70010-028_019388a3-ecda-7396-e063-6294a90a62b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA213186
- Marketing category
- ANDA
- Marketing start
- 2020-10-01
- 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 |
|---|
| 70010-028-01 | Ramelteon | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 70010-028-03 | Ramelteon | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 70010-028-05 | Ramelteon | 500 in 1 BOTTLE | TABLET | 500 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-028 | RAMELTEON TABLET [GRANULES PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20230729_a0a57843-81cb-474d-8e90-e04bbe93216a.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 |
|---|
| 70010-028-01 | 70010002801 | 100 TABLET in 1 BOTTLE (70010-028-01) | 100 tablet | 2023-05-15 | 0000-00-00 | No | No | Current |
| 70010-028-03 | 70010002803 | 30 TABLET in 1 BOTTLE (70010-028-03) | 30 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |
| 70010-028-05 | 70010002805 | 500 TABLET in 1 BOTTLE (70010-028-05) | 500 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |
| 70010-028-22 | 70010002822 | 60000 TABLET in 1 PAIL (70010-028-22) | 60000 tablet | 2020-12-18 | 0000-00-00 | No | No | Current |