Eszopiclone
- Product NDC
- 43063-795
- 11-digit product format
- 430630795
- Labeler code
- 43063
- Product ID
- 43063-795_415b59ae-84e5-550f-e063-6294a90af226
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA091124
- 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
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43063-795-30 | Eszopiclone | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-795 | ESZOPICLONE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20240927_4832cfbf-a540-46af-bb7d-3ba8e6bc783e.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 |
|---|
| 43063-795-30 | 43063079530 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-795-30) | 2017-10-09 | 0000-00-00 | No | No | Current |