Ramelteon
- Product NDC
- 63629-8531
- 11-digit product format
- 636298531
- Labeler code
- 63629
- Product ID
- 63629-8531_efc72bca-fc54-4a93-abb7-6c8621d8faf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 63629-8531-1 | Ramelteon | 30 in 1 BOTTLE | TABLET | 30 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8531 | RAMELTEON TABLET [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20240420_af1db3bf-1c7c-441e-8497-7c35f45fb00e.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 |
|---|
| 63629-8531-1 | 63629853101 | 30 TABLET in 1 BOTTLE (63629-8531-1) | 30 tablet | 2020-10-01 | 0000-00-00 | No | No | Current |