Ramelteon
- Product NDC
- 80425-0343
- 11-digit product format
- 804250343
- Labeler code
- 80425
- Product ID
- 80425-0343_2a9bf7d3-46de-0dfa-e063-6394a90a76a4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ramelteon
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA213815
- Marketing category
- ANDA
- Marketing start
- 2023-06-15
- 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 |
|---|
| 80425-0343-1 | Ramelteon | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0343 | RAMELTEON TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, 1 package rows | 20250102_fe2fc3b7-4600-c14e-e053-6394a90a2586.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0343-1 | 80425034301 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0343-1) | 2023-06-15 | No | No | Current |