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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESZOPICLONE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485440 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8826-3 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
| 68788-8826-6 | Eszopiclone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8826 | ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20250212_be25bb4e-d84f-4396-a78f-a668a207cf2d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |