Eszopiclone
- Product NDC
- 71205-581
- 11-digit product format
- 712050581
- Labeler code
- 71205
- Product ID
- 71205-581_dfa6f802-b9c1-4874-9556-0b88e48bcc58
- 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
- 1 mg/1
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71205-581_dfa6f802-b9c1-4874-9556-0b88e48bcc58
- SPL ID
- dfa6f802-b9c1-4874-9556-0b88e48bcc58
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Eszopiclone
- Generic name
- Eszopiclone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2014-04-15
- Marketing category
- ANDA
- Application number
- ANDA091166
- DEA schedule
- CIV
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| ESZOPICLONE | 1 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | UZX80K71OE |
| Rxcui | 485440 |
| Spl Set Id | edc03482-b013-448a-8cd9-2a17bd6d15e9 |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71205-581-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-581-30) | 2021-06-23 | No |
| 71205-581-60 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-581-60) | 2021-06-23 | No |
| 71205-581-90 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-581-90) | 2021-06-23 | No |
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 |
|---|
| 71205-581-30 | 71205058130 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-581-30) | 2021-06-23 | No | No | Historical |
| 71205-581-60 | 71205058160 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-581-60) | 2021-06-23 | No | No | Historical |
| 71205-581-90 | 71205058190 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-581-90) | 2021-06-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Eszopiclone | Proficient Rx LP | 2022-05-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |