Eszopiclone
- Product NDC
- 80425-0063
- 11-digit product format
- 804250063
- Labeler code
- 80425
- Product ID
- 80425-0063_2a98ff70-0364-7169-e063-6394a90adc74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA208451
- Marketing category
- ANDA
- Marketing start
- 2016-09-15
- 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
- Eszopiclone
- 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 | 485442 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0063-1 | Eszopiclone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 6 |
| 80425-0063-2 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0063 | ESZOPICLONE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250101_af86fca8-571e-0cac-e053-2a95a90ae402.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0063-1 | 80425006301 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0063-1) | 2016-09-15 | 0000-00-00 | No | No | Current |
| 80425-0063-2 | 80425006302 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0063-2) | 2016-09-15 | 0000-00-00 | No | No | Current |