ESZOPICLONE
- Product NDC
- 65862-968
- 11-digit product format
- 658620968
- Labeler code
- 65862
- Product ID
- 65862-968_a39aa520-c8ad-4f39-ad71-04a839474b5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESZOPICLONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- 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 | 485440, 485442, 485465 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-968-01 | ESZOPICLONE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
| 65862-968-30 | ESZOPICLONE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-968 | ESZOPICLONE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 2 package rows | 20220301_f18cc76f-82aa-4ad7-b8ce-5737733ee104.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 |
|---|
| 65862-968-01 | 65862096801 | 100 TABLET, FILM COATED in 1 BOTTLE (65862-968-01) | 2016-09-15 | 0000-00-00 | No | No | Current |
| 65862-968-30 | 65862096830 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-968-30) | 2016-09-15 | 0000-00-00 | No | No | Current |