Eszopiclone
- Product NDC
- 68788-8826
- 11-digit product format
- 687888826
- Labeler code
- 68788
- Product ID
- 68788-8826_be25bb4e-d84f-4396-a78f-a668a207cf2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA202929
- Marketing category
- ANDA
- Marketing start
- 2025-02-10
- Substance
- ESZOPICLONE
- Active strength
- 1 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8826_be25bb4e-d84f-4396-a78f-a668a207cf2d
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Generic name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2025-02-10
- Marketing category
- ANDA
- Application number
- ANDA202929
- DEA schedule
- CIV
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ESZOPICLONE | 1 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485440 |
| Spl Set Id | be25bb4e-d84f-4396-a78f-a668a207cf2d |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UZX80K71OE | ESZOPICLONE | 138729-47-2 | ESZOPICLONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8826-3 | 68788882603 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8826-3) | 2025-02-10 | No | No | Current |
| 68788-8826-6 | 68788882606 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8826-6) | 2025-02-10 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Eszopiclone | Preferred Pharmaceuticals Inc. | 2025-02-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |