Eszopiclone
- Product NDC
- 68788-8387
- 11-digit product format
- 687888387
- Labeler code
- 68788
- Product ID
- 68788-8387_e4ce3084-4759-4918-9eb2-065827f2e0f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA091166
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- Substance
- ESZOPICLONE
- Active strength
- 1 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Listing expiration
- 2027-12-31
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 |
|---|
| 68788-8387-3 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68788-8387-6 | Eszopiclone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8387 | ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250504_0102ea59-77b1-4e74-83ec-1d205563b55f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8387-3 | 68788838703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8387-3) | 2023-03-01 | No | No | Historical |
| 68788-8387-6 | 68788838706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8387-6) | 2023-03-01 | No | No | Historical |