Eszopiclone
- Product NDC
- 76420-352
- 11-digit product format
- 764200352
- Labeler code
- 76420
- Product ID
- 76420-352_4ca4de13-a880-98bf-e063-6294a90aa9f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA091166
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Substance
- ESZOPICLONE
- Active strength
- 1 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 | 1 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 |
|---|
| 76420-352-00 | Eszopiclone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 76420-352-01 | Eszopiclone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 76420-352-30 | Eszopiclone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 76420-352-60 | Eszopiclone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 76420-352-90 | Eszopiclone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-352 | ESZOPICLONE TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, 5 package rows | 20250524_838559f7-4b69-4831-bf50-ab37c6c24c2b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-352-00 | 76420035200 | 1000 TABLET, FILM COATED in 1 BOTTLE (76420-352-00) | 2025-05-22 | No | No | Historical |
| 76420-352-01 | 76420035201 | 100 TABLET, FILM COATED in 1 BOTTLE (76420-352-01) | 2025-05-22 | No | No | Historical |
| 76420-352-30 | 76420035230 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-352-30) | 2025-05-22 | No | No | Historical |
| 76420-352-60 | 76420035260 | 60 TABLET, FILM COATED in 1 BOTTLE (76420-352-60) | 2025-05-22 | No | No | Historical |
| 76420-352-90 | 76420035290 | 90 TABLET, FILM COATED in 1 BOTTLE (76420-352-90) | 2025-05-22 | No | No | Historical |