Eszopiclone
- Product NDC
- 68071-2403
- 11-digit product format
- 680712403
- Labeler code
- 68071
- Product ID
- 68071-2403_4cecb424-e5f2-e954-e063-6394a90a5a40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- OROPHARYNGEAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA091166
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Substance
- ESZOPICLONE
- Active strength
- 3 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485465 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-2403-3 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-2403 | ESZOPICLONE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210515_c24ec179-f869-746f-e053-2995a90aa1ff.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 |
|---|
| 68071-2403-3 | 68071240303 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2403-3) | 2021-05-14 | 0000-00-00 | No | No | Current |