Eszopiclone
- Product NDC
- 68071-3376
- 11-digit product format
- 680713376
- Labeler code
- 68071
- Product ID
- 68071-3376_1ce8fd7d-c659-0b3f-e063-6394a90ae539
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCarePharmaceuticals, Inc.
- Application
- ANDA202929
- Marketing category
- ANDA
- Marketing start
- 2014-04-25
- Substance
- ESZOPICLONE
- Active strength
- 3 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 | 3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485465 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3376-3 | 2024-07-10 | C162847 | 48780-1 | ba0f9c33-1b0b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 68071-3376-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1b0b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 68071-3376-3 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1b0b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 |
| 68071-3376-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1b0b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use eszopiclone tablets safely and effectively. See full prescribing information for eszopiclone tablets. Eszopiclone tablets, for oral use, CIV Initial U.S. Approval: 2004 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3376-3 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3376 | ESZOPICLONE TABLET, FILM COATED [NUCAREPHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240711_53fcee89-027a-13e5-e054-00144ff8d46c.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 |
|---|
| 68071-3376-3 | 68071337603 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3376-3) | 2017-07-10 | 0000-00-00 | No | No | Current |