Eszopiclone
- Product NDC
- 82804-076
- 11-digit product format
- 828040076
- Labeler code
- 82804
- Product ID
- 82804-076_e32746a8-6440-4b0a-a445-4467cf0329d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA091166
- Marketing category
- ANDA
- Marketing start
- 2014-04-15
- Substance
- ESZOPICLONE
- Active strength
- 2 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 |
|---|
| ESZOPICLONE | 2 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485442 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| UZX80K71OE | ESZOPICLONE | 138729-47-2 | ESZOPICLONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-076-30 | 82804007630 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-076-30) | 2024-02-21 | No | No | Historical |
| 82804-076-60 | 82804007660 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-076-60) | 2024-02-21 | No | No | Historical |
| 82804-076-90 | 82804007690 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-076-90) | 2024-02-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Eszopiclone | Proficient Rx LP | 2024-02-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |