Lunesta
- Product NDC
- 80725-011
- 11-digit product format
- 807250011
- Labeler code
- 80725
- Product ID
- 80725-011_4a1b20fc-a41d-41dd-a557-fa9333bb5c3b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Waylis Therapeutics LLC
- Application
- NDA021476
- Marketing category
- NDA
- Marketing start
- 2023-08-15
- Substance
- ESZOPICLONE
- Active strength
- 2 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lunesta
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESZOPICLONE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485440, 485442, 485465, 540407, 540409, 540411 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-011-30 | Lunesta | 30 in 1 BOTTLE | TABLET, COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80725-011 | LUNESTA (ESZOPICLONE) TABLET, COATED [WAYLIS THERAPEUTICS LLC] | 2 | Current NDC, 1 package rows | 20250110_3821f4b7-a3c8-4920-ba80-18aa96532c09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80725-011-30 | 80725001130 | 30 TABLET, COATED in 1 BOTTLE (80725-011-30) | 2023-08-15 | No | No | Current |