Eszopiclone
- Product NDC
- 70518-3576
- 11-digit product format
- 705183576
- Labeler code
- 70518
- Product ID
- 70518-3576_4f5b4d7d-0b6c-54af-e063-6394a90a7c29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA202929
- Marketing category
- ANDA
- Marketing start
- 2022-11-10
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3576-0 | Eszopiclone | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 5 |
| 70518-3576-1 | Eszopiclone | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 5 |
| 70518-3576-2 | Eszopiclone | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3576 | ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [REMEDYREPACK INC.] | 2 | Current NDC, Legacy NDC, 3 package rows | 20240116_61fd4655-060f-4393-a610-019d8b127058.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 |
|---|
| 70518-3576-0 | 70518357600 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-0) | 2022-11-10 | 0000-00-00 | No | No | Current |
| 70518-3576-1 | 70518357601 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-1) | 2025-06-17 | | No | No | Historical |
| 70518-3576-2 | 70518357602 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3576-2) | 2025-09-29 | | No | No | Historical |