Ramelteon
- Product NDC
- 0832-1250
- 11-digit product format
- 008321250
- Labeler code
- 0832
- Product ID
- 0832-1250_47e23ded-379f-0ed4-e063-6394a90ab270
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA213815
- Marketing category
- ANDA
- Marketing start
- 2020-10-26
- 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 |
|---|
| 0832-1250-11 | Ramelteon | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 0832-1250-30 | Ramelteon | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-1250 | RAMELTEON TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230331_2d22e6ae-2373-4a2f-8dda-d223230c6010.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0832-1250-11 | 00832125011 | 100 TABLET, FILM COATED in 1 BOTTLE (0832-1250-11) | 2020-10-26 | 0000-00-00 | No | No | Current |
| 0832-1250-30 | 00832125030 | 30 TABLET, FILM COATED in 1 BOTTLE (0832-1250-30) | 2020-10-26 | 0000-00-00 | No | No | Current |